Investigator Utility Bill Complaints Job Description Sample
Scientist Tech Support, Complaints Investigation
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life.
Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Complaint investigation and post market surveillance of hematology products. Investigate and process the complaints received from customers (internal or external) regarding Hematology products (calibrators, controls, reagents, instruments, hardware, software, results related, and Medical Event reportable). Investigation includes design/plan experiments and perform testing on hematology instruments.
Communicate with Medical Affairs, R&D, Quality and Technical Services personnel during the investigation of customer complaints. Record complete and accurate findings regarding each complaint investigation, including the test results, data review, customer response, conclusion and any action required. Pr
imary Job Function Proactively contribute to design control or process/product improvement activities and investigations. Perform or support test/process method modifications; recognize adverse trends/emerging issues; and propose/implement solutions.
Core Job Responsibilities Responsible for implementing and maintaining the effectiveness of the quality system. 1. Project Management
Manage product and process improvements independently using established principles and procedures. 2. Product and Process Improvement
Monitor performance of multiple manufacturing processes and products differing in nature but with recurring themes to recognize adverse trends and instigate improvement programs as required. Proactively contribute to design control; process and product improvement activities; and investigations.
May perform or support test and process method modifications. Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues. 3. Design Control & Risk Management
By standard practice (Operating Procedures) independently develops; and maintains risk management files and organizes data for risk management evaluation and decisions. 4. Complaint and Internal Investigations
Manage investigations; identify root cause and drive to resolution with minimal supervision. Provides audit inputs and support as required. 5. Technical Support
Develop and design experiments; analyze data and recommend next steps. 6. Sharing Knowledge
Presents technical information to management and may present externally to customers and Third Party Manufacturers (TPM). Shares knowledge and expertise with others in work group. Mentors or teaches others to facilitate timely resolution of product and process technical issues. 7. Strategic and Results Orientation
Demonstrates fiscal responsibility through support of product availability and improvements. Supervisory/Management
Responsibilities Receives general direction. Identifies, understands and resolves technical problems and operational issues.
Utilizes appropriate experimental, statistical and project management tools.
Capable of resolving different but recurring problems. Thinking is innovative but guided by standard practice/precedent.
Requires some specialized knowledge. Position Accountability/Scope Receives general direction. Identifies; understands and resolves technical problems and operational issues. Utilizes appropriate experimental; statistical and project management tools.
Capable of resolving different but recurring problems. Thinking is innovative but guided by standard practice/precedent.
Requires some specialized knowledge. Requires specialized knowledge of product or process design; standardization; performance anchors and modes of control.
Minimum Qualifications Higher Certificate; Ordinary or Honors Bachelor degree in scientific and technical field is desired or relevant combination of education and experience. 2 years’ related work experience. (Advanced degree(s) may offset required years of experience).
Proficient investigative and analytical skills preferred. Strong attention to detail; excellent written and verbal communication skills; strong critical thinking skills.
Ability to interact with individual/groups at all levels; good presentation skills Demonstrated strong initiative. Demonstrated experience coordinating multi-functional tasks and activities with other departments and organizations. Ability to identify priorities and function independently.
Proficient in hematology instrument operation, instrument troubleshooting, and data analysis. Hematology experience is a plus An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email email@example.com
Analytic Manager 3 - Customer Complaints Analytics Leader
The Wholesale Analytics group is part of Wholesale Relationship Strategies & Insights, and provides reporting and analytic support to all of Wholesale. The team functions as a key central analytic function for relationship and sales growth, and provides insight into Wholesale-wide metrics and reporting needs, developing innovative analytic solutions to support business growth and monitoring.
This group develops analyses and reports to support strategic growth, attrition, conduct risk, and any other areas where businesses may need analytic/reporting support. Specifically, this group supports multiple transformational business strategies and initiatives in Wholesale such as Customer 360, Wholesale Relationship Management Foundations (WRMF), CRM and pipeline analytics, customer segmentation, customer excellence, customer complaints and sales practices. This individual will lead a team within the Wholesale Analytics group that is dedicated to supporting the Wholesale Customer Complaints work being led by the Customer Excellence group within the Wholesale COO group.
This work may also expand into supporting other Customer Excellence strategies such as Customer Experience and Voice of the Customer. The successful candidate will facilitate the development of customer complaints dashboards, analyses, and presentations for executive level audiences. As such, they will be an expert at guiding their team in distilling vast information into succinct actionable insights, present that information with the story in mind, in a polished format that is relevant to senior leadership.
This leader will need to be comfortable leveraging data from multiple sources, internal and external. Experience with text analytics is a plus. They need to execute a vision with loosely defined business requirements, and anticipate business needs that may not be explicitly articulated.
They will be responsible for development and implementation of a comprehensive, consistent, and accurate analytics and dashboard development. Further, they will support our critical efforts to strengthen our insights-driven culture as an integral element of our business model and practices. This leader will drive and enable close partnerships with other analytic and reporting teams, Customer Excellence, LOB business partners, Wholesale Business Solutions (WBS), WRS&I Relationship Programs and Governance, and other partners as appropriate.
This leader will also foster partnerships with other analytic teams across the Enterprise to continue to drive WF consistency in analytic and reporting structures, and explore new innovative thinking/ideas to be leveraged by the team. As such, the successful candidate will effectively use of interpersonal and communications skills with tact and diplomacy, and effectively collaborate on projects. They will have an analytic curiosity, an ability to cultivate analytic talent and curiosity in others, a strong desire to dig deeper, and the ability to solve complex problems quickly and creatively. This leader will drive a team of analysts at varying levels in the execution of:
Identification of relevant metrics to provide insights into Wholesale customer complaints and customer excellence programs and strategies, including development of KRIs and KPIs; * Supporting complex activities related to business analysis by responding to requests from the Customer Excellence team as well as from lines of business, and conduct in-depth analyses and ad-hoc reporting.
Process development (and technology development in partnership with technology partners) to support the identification, monitoring, and reporting of KRIs, KPIs, and other metrics, including sourcing information for analytics development; * Providing actionable insights and make strategic recommendations to the line of business based on thought-provoking and sound analytics, both proactively and in response to business partners’ requests
Applying knowledge of business, customers, and/or products/services/portfolios to synthesize data to 'form a story' and align information to contrast/compare to industry perspective
Socializing and training of stakeholders regarding utilization and role of metrics in programs
- Preparing and producing thought-provoking dashboards to senior management and other stakeholders. This role will be located in Charlotte, NC. Team members support our focus on building strong customer relationships balanced with a strong risk mitigating and compliance-driven culture which firmly establishes those disciplines as critical to the success of our customers and company.
They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions. There is emphasis on proactive monitoring, governance, risk identification and escalation, as well as making sound risk decisions commensurate with the business unit’s risk appetite and all risk and compliance program requirements.
* 6+ years of experience in one or a combination of the following: reporting, analytics, or modeling * 2+ years of management experience
Ability to think strategically, implement, and deliver business objectives
Ability to coordinate completion of multiple tasks and meet aggressive time frames
Ability to negotiate, influence, and collaborate to build successful relationships
Excellent verbal, written, and interpersonal communication skills
Extensive knowledge and understanding of research and analysis How to Express Interest in This Job: Wells Fargo invites you to apply for this job at https://employment.wellsfargo.com/psp/PSEA/APPLICANT_NW/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&FOCUS=Applicant&SiteId=1&JobOpeningId=5388874&PostingSeq=1.
All offers for employment with Wells Fargo are contingent upon the candidate having successfully completed a criminal background check. Wells Fargo will consider qualified candidates with criminal histories in a manner consistent with the requirements of applicable local, state and Federal law, including Section 19 of the Federal Deposit Insurance Act. Relevant military experience is considered for veterans and transitioning service men and women.
Wells Fargo is an Affirmative Action and Equal Opportunity Employer, Minority/Female/Disabled/Veteran/Gender Identity/Sexual Orientation. Relevant military experience is considered for veterans and transitioning service men and women. Wells Fargo is an Affirmative Action and Equal Opportunity Employer, Minority/Female/Disabled/Veteran/Gender Identity/Sexual Orientation.
Administrative Technical Complaints Coordinator
Title: ADMINISTRATIVE TECHNICAL COMPLAINTS COORDINATOR Location:
US-NJ-Morristown Job Number: 17208922 CTG is seeking an Administrative Technical Complaints Coordinator to work at their client site in Morristown, NJ. This is an 11 month contract position that has the potential to extend longer. The maximum W2 hourly rate will be $26.00/hr (based on experience). DESCRIPTION
This position is in Technical Complaints, part of the Quality organization, located in Morristown, NJ.
The position Is responsible for ensuring that product technical complaints, received from various contact centers, are processed in accordance with SOPs, industry and BHC corporate standards, regulations and customer expectations.
Products mays include drugs, medical devices and consumer healthcare products. POSITION DUTIES - Case processing, including triage of cases, data entry, creation of letters to complainants and 3rd party companies, and secondary review of cases
Supports the technical complaint process through the administration of complaint sample returns, complainant follow-up activities, and coordination of investigation close-out
Interfaces with call centers, investigation sites, various client departments, and complainants as required, to obtain complete case information QUALIFICATIONS - HS degree required. Associate's degree preferred (Life Sciences) - 3 years work experience preferably in a regulated industry (healthcare preferred) - Organizational skills, team skills, computer skills – database environment, MS Word/Excel, ability to work in high volume atmosphere
Strong customer focus, with customer service experience preferred
- Good written and verbal communications skills CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan.
Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011). CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws. CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity.
Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran. Job: Technology & Healthcare IT
HourlyPosition Purpose: Receive, investigate, and respond to Member and Provider complaints including complaints received through State or Federal regulatory agencies. Assist with ensuring compliance with contractual requirements and federal and state government reporting and regulations.Assist with the development, update and maintenance of complaint and complaint-appeals policies and procedures including Member, Provider, and Regulatory complaint correspondence
Review and audit complaints against the Complaints Process and ProceduresMaintain Complaint and Complaint-Appeal Logs to include all contractual and regulatory-required information
Receive, process, track and maintain all Member, Provider and Regulatory complaints and complaint-appealsMaintain compliance with contract deliverables, State Contract with the Health & Human Services Commission (HHSC) and all state and federal regulations.Coordinate applicable internal and external customers to obtain the necessary documentation and information necessary to respond to a Complaint or Complaint-appeal TITLE: Complaints Coordinator LOCATION:
Smyrna, Georgia REQNUMBER: 1086961 COMPANY: Health Insurance Operations POSITION TYPE: Hourly
Complaints Specialist (Qa)- Westwood MA
At Surgical Specialties Corporation, we are motivated by enabling our customers’ success.
That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and the surgical professional well into the future. Our precision manufacturing expertise along with our highly targeted sales and marketing capabilities help us offer novel and differentiated medical device products to patients and physicians, as well as to other medical device manufacturers and distributors.
Commitment to the Customer, Sense of Urgency, Focus, Accountability, and Teamwork define our culture and our organization and drive everything that we do. We are seeking progressive, creative, customer oriented and highly skilled individuals for unparalleled opportunity. Bring your passion, energetic vision, and entrepreneurial spirit to work for a company that will reward your commitment and encourage your potential.
You can view current employment opportunities and apply online for a position with Surgical Specialties Corporation through our Online Career Center.
while reporting to the VP of QA / RA, the Complaints coordinator will act very independently inassisting the tracking and trending of incoming complaints. Overall
+ + Responsible for the creation and maintenance of complaint trending, including logging complaints and writing investigations. Handling of inquiries may also be required.
Ensure policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy
Highlight any potential reportable events or field action to QA/RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
Establish, deliver and maintain training materials for effective complaint handling, root cause analysis, CAPA initiation.
Assist the complaint administrator with customer/ complaint data
Provide support to the Surgical Specialties Mexico quality complaint team
Performs other related duties as assigned or required. Requirements Education:Bachelor Degree ; Nursing degree preferred Experience:Minimum of 1-2 years related experience, minimum 3 years in a clinical role (RN or clinical support role) Other Knowledge, Skills, Abilities or Certifications:
Must possess general office, communication and customer service skills, have typing ability, and be able to operate various office machines. Must be able to work independently once familiar with procedures. Computer, organizational and attention to details skills necessary.
Travel Requirements – 15%+ Physical Demands – Must be able to lift ten (10) pounds. Surgical Specialties Corporation is an Equal Opportunity Employer M/F/D/V
Pharma Complaints Representative I
Pharma Complaints Representative IAustin, Texas, United States at https://agn.referrals.selectminds.com/jobs/4488/other-jobs-matching/location-only Feb 05, 2018Post Date 177531Requisition # Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right. Join one of the world’s fastest growing pharmaceutical companies! At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight. Position Description Under general direction, The Pharmaceutical Complaint Representative I is responsible for handling inbound/outbound call inquiries, obtaining pertinent information, and creating cases for eligible complaints. Additionally, responsibilities include: processing complaints received by email and postal mail, retaining knowledge pertaining to over 80 products, and providing compensation of non-medical and adverse event cases. Under general supervision, Pharmaceutical Complaint Representatives I, process patients’ and doctors’ requests related to product quality complaints in a timely, accurate and professional manner. Their objective is to promote the growth of a strong customer base through creating positive customer interactions and building strong customer relationships. Main Areas of Responsibilities
Answers a minimum of 20 incoming calls per day. Answers telephone, written, or email inquiries on Allergan products, including, but not limited to, product quality complaints, reconciliation reports, misrouted calls, compensation requests, etc.
Maintains good call quality and a high accuracy rate. Demonstrates excellent written and communication skills when communicating with internal and external customers. Exhibits multitasking skills assisting with projects as required.
Independently develops and writes letters to customers on inquiries and non-medical complaints that are written at a level of expertise that can represent the high quality of standards mandated by the department and the corporation. Requests additional information when necessary so that customers' concerns may be addressed appropriately.
Receives and processes product complaints on pharmaceutical products. Assesses the need for, and, if appropriate, provides, processes, documents, and coordinates efforts to replace product or provide compensation to customers for all Allergan Pharmaceutical Drugs.
The decision-making is based upon information gathered from the customer (including end-users, health care practitioners, marketing, and sales personnel), as well as coordination with manufacturing QA departments. Complaint processing and documentation need to meet current Good Manufacturing Practices standards, and a high quality service to Allergan consumers is essential to maintain the philosophy of the corporation, customer satisfaction and good will.
Responsible for abiding by the quality processes associated with product complaint handling, procedures and controls to ensure that all complaints are processed in accordance with established company procedures and GQP-08-05. Obtains adequate information from incoming calls, emails, letters, and faxes to ensure proper documentation, investigation, and closure of each complaint.
Ensures all required information is obtained and properly documented to make sound regulatory reporting decisions. Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance. PreferredSkills/Qualification
Establishes andmaintains effective relationships with management, co-workers,subordinates and customers; successfully builds support for ideas withoutuse of hierarchical power; demonstrates personal integrity. Managesfeelings constructively rather than allowing them to dominate andundermine performance; exercises tact and diplomacy; good self awareness;accepts constructive criticism and feedback and uses suggestions to bestadvantage; considers the human side of problems as well as the technicalside. Works well in a team effort; shows willingness to take on newapproaches and additional responsibilities; provides information and/orassistance to others; strives for a win/win outcome.
Articulates ideasin a clear, concise and persuasive manner; professional podium skills;displays appropriate assertiveness when advocating point of view; activelylistens to others; encourages and listens to input before taking action;provides relevant and timely information to management, co-workers,subordinates and customers; prepares concise, easily read and understoodreports and recommendations; selects most appropriate means ofcommunication. Provides meeting leadership, management and facilitation.
Uses goodjudgment to make effective decisions within appropriate timeframes. Knowswhen to consider the big picture and when to reduce issues to componentparts; evaluates alternatives and solutions thoughtfully, objectively andquickly before making decisions; makes tough and even unpopular decisionswhen necessary. Trustworthy; stands up for convictions and values.
Anticipates,understands the totality of a business initiative and sees clearly whatneeds to be done and how to achieve it; consistently delivers oncommitments. Demonstrates flexibility of thinking.
Anticipates,understands and addresses changing needs. Creates new approaches that areturned into realistic plans and results. Deals well with ambiguity.Searches out challenging opportunities to change, grow, innovate andimprove systems and processes. Instills commitment to environmental andsafety awareness in daily work activities.
Clearly definesinternal and external customer and supplier expectations, needs and wants.Responds to customers' needs in a timely and courteous manner; takesinitiative to properly identify and resolve customer concerns; seekscustomer feedback; takes customers' interests into account when makingdecisions. Education
A High schooldiploma, with three to five years of previous experience, in customerservice or in a clinical setting and/or equivalent combination ofeducation and experience.
Manager, Global Device Complaints Management
Overview Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become. The primary focus of this position is to manage, train and motivate team members and to identify and lead the implementation of process improvements regarding complaint handling, medical device reporting and global complaint handling strategies. In addition this position provides routine communication to supporting departments (global level) as well as senior management. This position also ensures that complaint handling and medical device reporting processes are compliant with domestic and international regulatory agency requirements. The scope of this position is directly related to the global complaint management process and all processes related to complaint evaluations, complaint investigations and complaint trending. This position is indirectly related to quality systems, management review, corrective/preventive actions, customer service, regulatory affairs, medical/clinical affairs, sales and marketing as well as research and development. The position will include routine interaction and communication with internal business stakeholders and external business partners. This position will supervise direct reports.
Provides daily leadership to team members concerning complaint handling activities, reportability assessments and submission of medical device event reports.
Generates, revises and implements robust and compliant complaint handling and medical device event reporting procedures.
Develops training materials and trains associates on procedures, policies, work instructions and guidelines.
Reviews adverse event reporting determinations to ensure they meet domestic and international regulatory requirements (FDA, MEDDEV, CMDCAS, ISO, etc.) prior to submission, when required.
Develops and implements complaint event tracking and trending data collection tools.
Provides data, trending and detailed analyses to support regulatory submissions.
Ensures complaint handling target metrics are met on a routine basis and escalates issues, when required.
Leads, develops and implements corrective and preventive actions to address complaint handling and medical device event reporting issues, as required.
Identifies and implements business process efficiencies to ensure timeliness metrics are consistently met.
Acts as Subject Matter Expert for complaint handling responsibilities.
Directly supports Regional Compliance audits, domestic and international regulatory agency inspections and Notified Body audits.
Communicates with internal and external medical professionals and/or consumers in order to determine the need to report the complaint event to regulatory agencies.
Completes documentation associated with personal performance reviews and communicates personnel reviews to team members.
Develops personnel goals and objectives.
Lead project activities and associated action items regarding on-going complaint handling improvements efforts.
Routinely interacts with Site Quality Assurance, External Manufacturing Quality Assurance, R&D, Customer Service and Medical Affairs in order to ensure robust complaint investigations are conducted.
Assesses critical complaint events and engages appropriate management, when required. Key Relationships Internal customers/business partners:
Research and Development
Design Quality Assurance
External Manufacturing Quality Assurance.
Manufacturing Site Quality Assurance
Sales and Marketing
Quality Systems/Compliance External customers/business partners:
Physicians (including physician's staff)
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
Bachelor of Science degree required.
Minimum 5 - 7 years related work experience within a medical device or pharmaceutical company required.
Minimum of 2 years experience in a senior lead or Supervisory role with direct oversight of personnel required
Be Aware of Recruiting Fraud Valeant is an EEO/AA employer M/F/D/V. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read . Refer this job to a friend Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
CategoryQualityPos. TypeFull Time
QA Area Specialist - Complaints Job
Requisition ID 54350BR Title QA Area Specialist
- Complaints Job Category Quality Job Description No relocation assistance will be provided for this position. Position Purpose:
Timely review, approval & closure of Internal/Customer complaints. Accountabilities: Support, review & approve complex cross-functional investigations related to Internal/Customer Complaints.
Ensure adequate standards for the processing of Internal/Customer Complaints.
Ensure timely review, approval & closure of Internal/Customer Complaints including corrective & preventive actions. Provide appropriate performance management metrics for Internal/Customer Complaint processes. Participate in & support the audit management team as needed during internal & external audits & inspections.
Support sourcing & Quality Assurance (compliance) in the quality assessments of & working relationships with internal & external suppliers. Perform other duties as assigned. Education: BA/BS in life sciences or related field, or an equivalent combination of education & experience.
Experience: Minimum of 2 years of Quality Assurance and/or related experience in the pharmaceutical or medical device industry. Demonstrated expertise in Good Manufacturing Practice regulations & investigational skills (e.g. root cause analysis & systematic problem solving). Knowledge of Novo Nordisk products is preferred. Technical/Process/Functional
Working knowledge of Novo Nordisk production processes & products. Expert knowledge of US, EU regulations & guidelines & ISO standards. Excellent written & verbal communication skills.
Excellent computer skills in MS Office, MS Project, PowerPoint, etc. Experience in the use of practical problem solving & LEAN tools. Organization/Planning:
Demonstrated excellence in time management, organizational & project team participation skills. Physical & Other
Able to work in an open office environment with the possibility of frequent distraction.
Occasionally moves equipment &\or supplies weighing up to 33 pounds within the facility using various body positions. Constantly operates a computer & other office equipment using hands. EEO Statement: Novo Nordisk is an Equal Opportunity Employer
M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status. Department QA Compliance Position Location US
Clayton, NC City Clayton State/Provinces US - NC Job/Position Country US At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities.
That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness With a career at Novo Nordisk, you’ll feel a difference right from the start.
It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S.
Toll Free number at 1-855-411-5290 or click on the following link to submit your request: https://www.surveymonkey.com/r/novoaccommodation . Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.
Consumer & Community Banking Compliance Manager – Complaints Intelligence Compliance Analytics Vice President
The Compliance Department of JPMorgan Chase & Co ensures the development and maintenance of a strong compliance culture by working closely with the business, legal, risk, and audit functions to provide expertise on regulatory compliance matters. The primary role of the Consumer & Community Banking (CCB) Complaints Intelligence Compliance team (CIC) is to perform monitoring, analysis, and regulatory advisement of compliance risk related to applicable rules, laws and regulations governing the Line of Business (LOB) complaint management functions, as well as determining potential compliance risks resulting from analyzing the Firm’s complaints.
This position partners closely with the Chief Compliance Officers, LOB Compliance Officers and Business Owners. The Complaints Intelligence Compliance Policy Officer is seeking a highly motivated analytical thinker with an interest in understanding the business operations and associated complaint risk that could span across multiple lines of businesses both within CCB and Firmwide. The scope of work begins with the complaint data within each of the lines of businesses. Role expectations and job responsibilities include: · Think holistically about business processes; Design, analyze historical trends and implement data analytics, trend analysis, validation of source system information and other required controls over the line of business practices that are highlighted in complaint data. · Complete and summarize data analyses, to include several alternative data sources, against internal and external complaint data. · Proactively recommend ways to improve the complaint analytics processes · Present your results and recommendations clearly and concisely to senior management and drive change across multiple lines of businesses · Degree in finance, economics, statistics or other quantitative fields · Minimum 3-4 years’ experience in an analytical role · Proficiency in MS Office (especially Excel) · Exposure to SAS/SQL is required · Strong analytical and problem solving skills · Ability to respond to complicated and unclear production issues · Excellent interpersonal & communication skills · Strong work ethic, self-motivated, able to set effective priorities to achieve immediate and strategic goals · Capable of working in a dynamic environment and managing multiple projects with tight timelines Risk, Regulatory, Compliance, Legal or Audit experience (5+ years) preferred
General Job expectationsinclude: ·
Lead the complaints program andmanage to the Compliance Pillars and Practices and align CIC Goals and
Objectives o Be a subject matter expert on the Firmwide Complaint Policy. o Aggregate vertical line of business complaint data and monitoring results to provide a comprehensive view of consistencies and process gaps between the CCB Lines of Businesses. · Knowledge of consumer Laws / Rules / Regulations andthe intersection between the Office of Legal Obligations, Compliance RiskAssessment, and Complaints Compliance o Knowledge of the Office of Legal Obligation program, including mapping of legal obligations to Compliance Relevant Risks, and the specific legal obligations which govern the complaint handling process. o Understand and translate the Firmwide Compliance Risk Assessment & Management Process results into monitoring and reporting, including the demonstration of applicability and coverage of legal requirements (obligations). o Assess a law / rule / regulation, define, and articulate the compliance risk for the business. JPMorgan Chase is an equal opportunity and affirmative action employer Disability/Veteran.
Product Quality Surveillance Senior Specialist II – Commercial Complaints
Primary Role The Product Quality Surveillance Specialist – Commercial Complaints is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for Shire’s pipe-line products and appropriate support for in-line products to enable a sustainable existence on the market.
Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other Shire functions / stakeholders across the Business to execute product quality surveillance strategies specifically Product Quality Complaint administration. This includes, but is limited to Product Quality Complaints, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions into post marketing product quality surveillance.
Actively involved in daily operations and coordination to meet schedules and resolve issues. Escalates to management when challenges occur. Actively involved in resolution of complex problems.
Post Marketing Product Quality Surveillance:
Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
Effective global Product Quality Compliant Handling
Effective global Product Annual / Periodic Product Quality Review
Effective global Product Recall Management
Support the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of Shire and Shire’s Suppliers
Specifically the Complaint Specialist II shall:
Process global commercial / clinical product Quality Complaints received
Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations
Critical evaluation of Customer Report complaints for serious cGMP and Device/ Combination product violations.
Assists with investigations on higher risk complaints, such as those that may or have led to Regulatory /Field actions. Lead investigation meetings as needed.
Performs Management review and final closure in TrackWise of Patient Inquires, Partner Notifications and Customer Report Complaints. Escalates potential Regulatory /Field actions to management.
Point of contact for International colleagues and LOC contacts and provides guidance to global partners.
Liaise with International Quality and global PQS Staff to ensure intake of appropriately redacted international complaint data is received, assessed and processed and escalates potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately
Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions
Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management.
Primary Contact for Pharmacovigilance for reconciliation of AEs and Complaints. Assesses Complaints for reportability and categorization. Communicate adverse events reported in conjunction with PQCs to Shire PVRM.
Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection investigation.
Coordinate pharmacy credits for returned product through Shire Customer service.
Coordinate process and review PQC investigations performed at contract site manufacturer packagers and Shire site investigations in conjunction with Quality Assurance.
Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combinat ion product cGDPs) in conjunction with technical and quality SMEs as appropriate.
Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant or communicate via the relevant international Shire QA to ensure local communication requirements are met.
Contact Trainings for lead of PQC team and external partners. Participate in third party call monitoring to ensure correct communication strategies are being utilized.
Subject Matter Expert and primary contact for TrackWise Complaint process. Identifies system changes and enhancements. Initiates and drives system changes to implementation.
Assigns and conducts training to new employees on PQC processes
Perform Trend and Key Performance Indicator Analysis
Conducts in depth analysis of complaint trends. Evaluates trending data and selects methods for in depth analysis based on data and results.
Responsible for completing complaint trending for the Annual Product Review and authoring Complaint section summaries.
Develops and implements actions associated with product quality complaints and trends are appropriately assigned and implemented.
Compiles and communicates product quality complaint performance measures and Product Complaint Quality Management system measures and associated action plans to Management.
Review and Confirm Compliance Index reports for accuracy. 10%:
Acquisition & Integration Support:
Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including but not limited to; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring.
Lead implementation of TrackWise Complaint workflow changes as TrackWise SME. 5%:
Inspection support and Compliance
Primary Contact for generation of reports for management and inspections as required.
Maintain awareness of MHRA/HPRA/EMA/FDA/DEA, etc. regulatory actions that may affect Shire’s products.
Supports regulatory reporting and submissions as applicable.
Keep informed of all regulatory changes, rulings and current industry practices concerning Post Marketing Surveillance activities.
Primary backup to management in support of regulatory inspections regarding Shire products and post marketing product surveillance activities.
Primary backup to management in support of regulatory notification or market correction activities (i.e. field alert and recall activities)
Initiate, author, revise or assist in the review of SOPs, and other Shire cGMP documentation including but not limited to CAPA, Deviation, etc) Education & Experience Requirements
MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 8 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience.
The Senior Specialist II will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.
Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.
Strong working knowledge of electronic data management systems (e.g. TrackWise and Master Control)
Strong working knowledge of Microsoft Office applications (e.g. Word, Excel, Power Point)
Other Requirements Limited Travel may be required (0-10%) Equal Employment Opportunity Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf Reasonable Accommodations Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information. Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
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