Manager Quality Control Job Description Sample
Manager, Quality Control
Leads a high performance team that executes effective and compliant Quality Control processes. Responsibilities include:
Sets daily, weekly, and monthly team/individual goals required to meet corporate goals, demand, and regulatory requirements
Develops and tracks applicable metrics
Inspires the team to understand, meet, and exceed their personal and team goals, ensuring that everyone has the proper training and tools to do so
Holds team accountable for results and takes quick, innovative action to recover when performance falls below target
Selects, trains, and develops highly qualified and motivated inspectors to execute quality plans (QIRs) and competently operate various kinds of manual, automatic, and advanced inspection measurement equipment
Eliminates waste in the department through deployment of lean manufacturing techniques and optimizes existing inspection processes through six sigma problem solving tools
Defines, documents, and establishes quality procedures necessary for successful and compliant operation of the department
Controls non-conforming materials and executes corrective and preventive action (CAPA) on related QC processes
Identifies and deploys process improvements necessary to deliver year over year budgetary and product innovation targets
Partners with Quality Engineering to qualify and validate inspection equipment and processes
Confidently and successfully communicates performance and initiatives of the department to cross-functional team members at every level of the organization
Personally grows through self-development initiatives such as cutting edge seminars or staying abreast of immerging trends in the industry
Maintains confidentiality of information provided by company and shareowners
Develops and maintains collaborative working relationship with other managers
Partners with others to drive engagement throughout all levels of the facility
Operates as a self-starter who doesn't wait to be told what to do
Demonstrates a willingness to roll up your sleeves and get your hands dirty
Has an "Attitude of Gratitude"
Embraces and promotes the unique NuVa culture
This role is responsible for the overall success of the quality control operation. This will include meeting and exceeding lead time and output goals, working with functional teams to improve customer fulfillment metrics, ensuring capacity meets demand with minimal overtime, holding all shareowners accountable for productivity goals and proper maintenance and care of company resources (i.e. Preventive Maintenance, 5S, etc.), and ensuring all shareowners are performing activities consistently and compliant to all organizational procedures and global regulatory regulations.
Bachelor's degree in an engineering, technical, or business discipline
7 years of experience in a medical, aerospace, or other highly regulated environment in a Quality Inspection or Engineering capacity
3-5 years of experience in management
2 years of experience in an FDA regulated environment
Demonstrated experience with the commonly used quality tools such as histograms, Pareto charts, and process flow charts
Demonstrated experience with problem solving and continuous improvement tools such as DMAIC, PDCA, and Kaizen
Proficient and accurate in Microsoft Office applications such as Excel and Access
Experience in 21 CFR 820/803/1270/1271, ISO 13485, or European Medical Device Directive environments
Lean Six Sigma Certification
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The "EEO is the Law" poster options are available
Manager - Quality Control
The Manager – Quality Control manages the activities and associates of a quality control group in efforts that relate to the release, stability, drug product characterization, provable acceptable range (PAR) studies, validation studies and other regulatory reportable testing activities. This individual is responsible for the development, implementation and maintenance of quality control systems. The Manager – Quality Control oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. This individual makes recommendations for corrective action necessary to ensure conformity with quality specifications and ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Responsible for GMP compliance as related to the laboratories, equipment and staff.
Trains others to independently execute QC test methods and practice all GMP related procedures.
Maintains a database of QC data, as applicable, to observed trends, perform statistical analyses and/or define appropriate specifications and alert limits.
Understands regulatory requirements and their application as suitably scoped to either support early phase or late phase/commercial release and stability efforts.
Develops strategies to ensure effective achievement of objectives by delegating responsibilities and organizing work flows while monitoring and evaluating the completion of tasks and projects.
Collaborates with other senior level personnel to ensure consistent application of company policies and practices as well as promoting new policies and programs tactfully and authentically.
Provides day to day management of a quality control group and the application of related QC systems
Leads investigations relating to the QC laboratory as well as the applications of any corrective and preventative actions.
Maintains equipment related data for trending, continuous improvement and application of effective preventative maintenance procedures.
Ensures effective and efficient operations of the laboratory in terms of workflows, people flows, laboratory equipment, and staff training;
Maintains laboratory supplies and inventory.
May serve as point-of-contact for instrument repairs, calibrations, qualifications, validations and maintenance; and provides technical input to purchasing new equipment.
May organize and participate in vendor negotiations, product and software evaluations, tutorials and facility modifications.
Responsible for development and execution of tracking procedures for consumable usage, equipment usage/repair.
Inputs budgetary requirements and monitors expenditures.
Works closely with Analytical Development to ensure new and existing analytical methodologies are appropriately written and/or developed for use in the QC laboratory.
May participate in contract laboratory audits on an as needed basis to ensure compliance to GMP principles and/or established Quality Agreements as well as manage associated testing activities
Ensures effective performance management process is in place and specific development plans implemented for each team member.
Responsible for training and mentoring associates in the Analytical Development & Quality Control Department.
Assists with talent recruitment and leads a highly motivated, efficient and effective team.
Education and/or Experience:
Bachelor's degree in Chemistry, Biology or related scientific field required.
Minimum of seven years of experience working in a cGMP regulated environment executing or overseeing Quality Control testing and related activities required.
Prior supervisory and/or managerial experience preferred.
- This individual supervises a team of Quality Control Analysts.
Experience in MDI/DPI analytical test methods preferred (i.e. Andersen Cascade Impactor and Emitted Dose Techniques) preferred.
Previous participation in regulatory audits preferred.
Thorough knowledge of HPLC, GC, FTIR and various other analytical techniques required.
Experience with statistical data analysis, DOE, HPLC software systems, trending analysis preferred.
Experience with the full life-cycle of developing and validating analytical methodologies
A strong foundation in the principles of cGMP.
Ability to apply applicable regulations (FDA, EU, Japan, USP, ICH, etc.) in a phase appropriate manner required.
Must be proficient in MS Office Suite.
Prior experience with Empower or similar, JMP or similar, experience with an ELN required.
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
Excellent oral and written communication and presentation skills
Excellent organizational skills and attention to detail are essential.
Ability to manager both day-today operations as well as project work.
Ability to prioritize and multi-task successfully in a fast paced environment.
Demonstrates appropriate safety consciousness.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Ability to lift up to 20 lbs.
Ability to stand for long periods of time
This position requires minimal travel; average travel for this position less than 10% with some variation based upon the demands of the business imperatives
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Ability to work safely and conscientiously in a laboratory environment; wear appropriate personal protective equipment; communicate with others in the laboratory to mutually ensure continued safe laboratory practices.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Manager Quality Control
About the OrganizationMission Statement:
Oncobiologics is a publicly traded biopharmaceutical company focused on the advancement of its pipeline of biosimilar products, two of which are currently in clinical development. Led by a team of biopharmaceutical experts, Oncobiologics operates from a state-of-the-art 40,000 sq. ft. fully-integrated R&D and manufacturing facility in Cranbury, NJ. The company employs its BioSymphony development model to ensure that biosimilar assets meet the stringent requirements of U.S. and European regulators, while also achieving accelerated development and technical excellence in creating affordable medicines for global patients who so urgently need them.
Oncobiologics provides a scientifically disciplined and speed-to-market approach to biosimilar development. By leveraging its scientific talent and technical infrastructure, the company has established a unique CMC engine designed to provide scientific rigor, speed and cost efficiencies. Through these capabilities, Oncobiologics is uniquely positioned to deliver a robust CMC package as required by the FDA, EMA and other regulatory bodies. The company is executing a commercial strategy to advance its biosimilar assets to global markets.
Oncobiologics actively fosters a collaborative, entrepreneurial culture. With years of experience in large organizations, the Oncobiologics team understands the critical importance of agile, rapid decision-making and strives to infuse all activities with urgency, creativity and disciplined thinking.
Founded January, 2011
Focused on the development of 'large molecules' (i.e., biologics) Description
Opportunity and Summary of Position:
The Quality Control Manager oversees Quality Control testing of Oncobiologics Biosimilar products including raw materials, cell banks, in process intermediates, drug substance and drug product. The Quality Control function at Oncobiologics operates under CGMP and this position is directly responsible for maintaining compliance with FDA, ICH and international regulations. In conjunction with Quality Assurance, the Quality Control function at Oncobiologics ensures that products meet established specifications prior to release. The Quality Control Manager is also responsible for management of the staff performing Quality Control testing at Oncobiologics and for the oversight of contract laboratories that perform Quality Control testing on behalf of Oncobiologics.
The Quality Control Manager will report directly to the VP of Quality of Oncobiologics.
Responsible for the operation of Oncobiologics Quality Control and Stability Labs which provide QC Chemistry and Bioassay support.
Oversight of contract laboratories, including those providing QC Chemistry and QC Microbiology.
Management, development, training and leadership of Quality Control Staff.
Partners with Analytical Sciences to ensure successful development of test methods.
Oversees the transfer of methods to Quality Control and the stage appropriate validation of methods.
Plans and executes QC testing and performs data review to ensure accuracy, completeness and validity.
Ensures continuous improvement in productivity and quality.
Investigates issues related to Quality Control of Oncobiologics products.
The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:
MS or PhD in Chemistry or related subject area.
Will consider BS with experience
Qualifications and Skills
Minimum ten years of experience in quality control of monoclonal antibodies in varying stages of development from pre-clinical to commercial. Small molecule experience is a plus.
Knowledge of the following methodologies is necessary: Bioassay, Bioburden, CE-SDS, CEX-HPLC, ELISA, Endotoxin, HCP, HILIC, icIEF, Pro-A HPLC, qPCR, rProtein A, rDNA, SE-HPLC, SE-UPLC and Sterility.
An attractive compensation package will be offered to the successful candidate. It will include a competitive base salary and incentive bonus.A benefits package customary to the position will also be provided including 401k match, medical and dental.
LocationOncobiologics EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.
Manager, Quality Control
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Manager, Quality Control.
The purpose of this position is to provide leadership and oversee the raw material and reference material programs in the Quality Control Department.
Responsible for daily raw materials laboratory operations including trending, scheduling, staffing, training and troubleshooting to ensure all operations are in full compliance with established Standard Test Methods, compendial methods, vendor methods and safety guidelines.
Collaborate with QA and Supply Operations to forecast incoming raw materials that require testing.
Contract lab management to include: direct communication with contract labs, coordination of outsourced testing, collaborating and advising on OOS investigations from contract labs and overseeing/coordinating method transfer to contract labs as needed.
Manage both the raw material and reference standard programs including driving change controls and document change revisions for updates to specification documents as needed.
Evaluate and potentially implement program for reduced testing of raw materials.
Oversee the following QC lab support functions; glassware cleaning, consumables inventory/ordering/stocking, raw data package management/scanning/archiving, chemical inventory, reference standard ordering/qualifying/shipping out for testing.
Provide effective leadership including setting individual objectives, employee evaluations, providing performance feedback, recognizing employee contributions, coaching and developing staff.
Provide guidance and risk assessment for the resolution of discrepancies, OOSs, Unexpected results, lab investigations and Corrective and Preventative Actions.
The qualified candidate will possess the following:
B.S. in science or technical field from an accredited college/university or relevant industry experience.
Minimum 8+ years of experience in pharmaceutical/Biotech industry or an equivalent combination of education and experience.
Experience in wet chemistry methods, chromatography methods and particle size testing required.
Experience with establishing specifications and revising specifications as well as familiarity with keeping up to date on compendial method revisions.
Experience with managing contract labs.
Previous leadership or supervisory experience required.
Working knowledge of cGMP, regulatory compliance (US and other international agencies), and Agilent OpenLab ECM
Experience providing scientific input, data analysis and written reports for failure investigations.
Practical knowledge and sound understanding of methods development, validation and regulatory submission.
Effective oral, written, and interpersonal English communication skills.
Ability to multi-task with good adaptability to changing business requirements in a dynamic corporate and QC environment.
Equal Opportunity Employer/Veterans/Disabled
Manager Quality Control
Manager Quality Control
Requisition Id: 45753
Business Unit: Supply Chain
Dayton, NJ, US, 08810
1st Shift, Monday
Logistics done differently.
At XPO Logistics, our employees are our biggest asset. And we need leaders who will provide guidance and education, as well as ensure organizational policies and procedures are understood and followed. As the Manager Quality Control, you will be responsible for overseeing the Quality and Inventory Control Department. On our team, you'll have the support to excel at work, and the resources to build a career you can be proud of.
Pay, benefits and more.
We are eager to attract the best, so we offer competitive compensation and a generous benefits package, including full health insurance (medical, dental and vision), 401(k), life insurance, disability and more.
What you'll do on a typical day:
Maintain vigilant focus on inventory to ensure tens of thousands of SKUs are accurately warehoused and managed to minimize lost and non-moving inventory
Investigate all facets of facilities operations to troubleshoot processes and make recommended improvements
Provide leadership and training for team members and facility in order to accomplish company goals and objectives
Ensure that facility/department training status and setup is reviewed at the required frequency, and the training requirements are met in a timely manner
Schedule, review, and follow-up on work instructions with supervisors by designated areas of responsibility
Coordinate activities for team members, ensuring effective use of productive working hours
Support plant operations in identifying Lean process improvement opportunities
What you need to succeed at XPO:
At a minimum, you'll need:
7 years of experience in quality and inventory in a distribution or warehousing environment
Experience in AS9100 or ISO environment
Previous supervisory experience
Strong time management skills and ability to work well under deadlines
Excellent verbal and written communication skills
Proficient with Microsoft Office (Word, Excel and Outlook)
Self-motivated, strong problem solver with excellent analytical and great math skills
Availability to travel up to 25%
It'd be great if you also have:
Bachelor's degree or equivalent experience
Experience with warehouse management and inventory management software
Knowledge of MS Access
Be part of something big.
XPO provides cutting-edge supply chain solutions to the world's most successful companies, including Disney, Pepsi, L'Oréal, Toyota and many others. We're the fastest-growing transportation company on the Fortune 500 list and we're just getting started.
We are proud to be an Equal Opportunity/Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, sex, disability, veteran, or other protected status.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All employees may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Nearest Major Market: New Jersey
Manager, Quality Control
Are you self-motivated and eager tounleash your full career potential? ServiceLink is in search of a candidate uniquely qualified with theideal blend of experience and talent to fill the position of Quality Control Manager. The successful candidate will possess soundjudgment, sharp insight, and exceptional analytical and communicationskills. If you are confident in yourability to strengthen the reputation of trust and confidence we hold among ourclients, we invite you to apply today. This is an exciting time to become a part of ServiceLink, where thedemand for exceptional performance is rewarded with unlimited opportunities forrapid career progression.
A DAY IN THE LIFE
In this role, you will…
Direct the department's Quality Control (QC) policies andprocedures for processing of Valuation products
Monitor and track post-delivery revisions to develop applicableworkflow changes
Coach and provide role development advice to staff
WHO YOU ARE
You possess …
A penchant for excellence. You will use your strong attention todetail to maintain our quality standards.
The ability to multitask in a fast paced environment, especiallythe ability to work in multiple systems at once.
Excellent verbal and written communication skills.
The ability to quickly learn new skills, processes andprocedures.
WHO WE ARE
About us …
ServiceLink is a mortgage servicescompany headquartered in Pittsburgh, PA that helps clients in the lendingindustry and beyond achieve their strategic goals, realize greater efficienciesand better serve their customers by delivering best-in-class technology,services and insight with a relentless commitment to upholding the higheststandards of quality, compliance and service.
ServiceLink, its affiliates and subsidiaries,is an Equal Opportunity employer. All qualified applicants will receiveconsideration for employment without regard to race, color, religion, sex, age,disability, protected veteran status, national origin, or any othercharacteristic protected by applicable law.
Essential functions are the basic jobduties that an employee must be able to perform, with or without reasonableaccommodation.
DETAILED JOB DUTIES
Direct the department's Quality Control (QC) policiesand procedures for processing of Valuation products
Monitor and track post-delivery revisions to developapplicable workflow changes
Coach and provide role development advice to staff
Ensure that all steps of the QC valuation process forthe department are completed accurately and within the required SLA (ServiceLevel Agreement) timeframes
Responsible to maintain departmental productivity andquality goals/metrics
Maintain compliance with State and Industry regulationsincluding Appraisal Independence
Extensive knowledge of appraisal industry guidelinesand products so that valuation quality meets defined standards
Plan, develop, and implement policies and procedures toimprove the operating quality and efficiency of the department
Analyze and document business processes and problems
Develop solutions to enhance efficiencies
Conduct departmental meetings as needed
Coordinate with management to manage appropriate staffing levels, conduct interviewsand hire needed staff
Ensure appropriate escalation paths are followed
Participate in client audits, regular performancecalls, and site visits
Communicate regularly with Senior Management ondepartment operation protocols and improvements
Maintain a positive, professional business relationshipwith vendors and internal staff
Perform all other duties as assigned
10 years' management experience in realestate appraisal, bank or finance lending, AMC or mortgage company experience
College degree preferred
Prior management experience in QC Valuationswith knowledge of standard Valuation practices and procedures including:
USPAP- Role may require the taking andpassing of USPAP training
BPO Standards & Guidelines
Production and Operational Roles
Knowledge of Valuation processes, procedures,and technology
Exceptional customer service, communicationand writing skills
Ability to read, write and maintainoperational reports and workflows
Strong attention to detail and multi-taskingabilities
Manager, Quality Control
Wolverine Advanced Materials produces and sells performance-critical, specialty elastomer-coated metals used in gaskets for automotive & industrial applications; automotive brake noise insulators and NVH (noise, vibration & harshness) damping solutions for automotive. Wolverine employs approximately 600 people worldwide and has manufacturing operations in Blacksburg, Va., Leesburg, Fla., Germany, and China, as well as sales & technical offices in Michigan, Germany, Japan, China, Brazil, and India.
The Quality Manager will lead and drive the quality related aspects of the manufacturing strategy for the two manufacturing plants in Blacksburg, Virginia. This position will support the quality efforts for the team by using and deploying the Wolverine (WAM) Quality System. Provide quality support to customers, suppliers, partners, and the support/service of other functions on the core team. Manage the quality strategy of the project team to facilitate continuous production and improvement of products consistent with established industry standards, government regulations and customer requirements. This position has the responsibility for driving and aligning the quality system and practices for the broad manufacturing team.
Deploy the Quality Management System, which include the Quality Manual with associated policies and procedures that comply with international Quality standards as well as WAM practices for the Blacksburg plant.
Strategically define the Critical to Quality elements of the product/process, and the knowledge to effectively analyze, assess and mitigate the risks associated with any potential failures.
Champion the deployment and application of the Quality System throughout the two manufacturing facilities in Blacksburg, VA. To include the tracking, monitoring, and reporting related to the level of deployment.
Ensure the plants comply with applicable company, customer and industry-specific Quality requirements by conducting the necessary audits and assessments and determine system effectiveness.
Continually improve the effectiveness and efficiency of the Quality Management System through the use of the Quality policy, Quality objectives, audit results, analysis of data, management review, and corrective / preventive actions.
Ensure the utilization of defined processes that represent a structured, disciplined, and repeatable framework for the planning and execution of the Manufacturing Strategy program and projects.
Provide support to the Supply Chain Management team relative to Supplier Quality activities of the project as well as provide Quality interface, expertise and support to the suppliers and partners. This includes the feedback of supplier performance to suppliers.
Analyze key Quality-related operational metrics related to both the plant dashboard and customer systems (if applicable) and perform periodical reviews to evaluate results and establish action plans to close the gaps at an operational level.
Drive the implementation of best / transferable practices for the Blacksburg plant to establish world class equality.
Recommend new or leading-edge technologies, methods, tools and procedures on the fields of quality assurance and continuous improvement to proactively address changes in the business environment.
Skills and Experience
Bachelor's Degree from an accredited institution required
5-7 years of quality / operational excellence experience
Must be legally authorized to work in the United State without company sponsorship
Experience leading cross functional teams and/or direct reports
ISO 9001 Lead Auditor
IATF 16949 Lead Auditor
American Society for Quality Certified Quality Engineer (CQE)
Six Sigma Green or Black Belt
Experience with Minitab, Excel
AIAG Core Tools Certified
Problem solving skills such 8D RedX, Fishbone Diagram
Hands on mechanical / manufacturing experience
Demonstrated knowledge of Quality assurance and Continuous Improvement methods, approaches and tools, methodologies
In-depth experience with the practical application of Quality tools, Six Sigma, and Lean Manufacturing methodologies
Demonstrated knowledge of Quality Management Systems
Strong ethics, values and the ability to influence others' decision making
Process oriented and ability to contribute to continuous improvement
Excellent communication and interpersonal skills
Solid computer skills
Ability to effectively influence and impact across work groups and at all levels in the organization.
Wolverine Advanced Materials is an Equal Opportunity Employer
Manager, Quality Control
The Manager, Quality Control provides strategic and tactical guidance to Quality Teams.
Duties and Responsibilities:
Provides strategic and tactical guidance to our Quality Teams.
Provides leadership to department staff by developing, managing, leading, supporting and coaching members ensuring continual development of business competencies.
Facilitates business process improvements.
Ensures team conformance to policies and procedures.
Interacts with engineering and production to drive quality initiatives and best practices; Develops process improvements and resolves problems and issues.
Evaluates and monitors employee performance through performance plans and assessments; Develops performance objectives.
Assesses inspection requirements and assigns inspection projects and tasks to inspection personnel.
Train personnel in the implementation of inspection policies and procedures.
Develops budget plans for assigned area.
Develops, manages and maintains an organization structure to support the quality function.
Resolves employee conflicts.
Troubleshoots and solves inspection issues.
Some travel may be required both domestic and internationally.
Manages supplier approvals, audits, and improvement initiatives.
Ensures compliance to FAA regulatory requirements.
Establishes metrics for monitoring product and manufacturing performance.
Coordinates on-site meetings with regulatory and supplier officials to facilitate quality system development.
Honda Aircraft Company is an Equal Opportunity Employer*
Education, Work Experience, Certification and/or Licensure:
BA/BS degree in a technical field from an accredited four year college or university program (i.e.- Engineering, Quality, Science) is preferred.
Minimum of 8 years of leadership experience required.
Previous verifiable experience as a DAR/DMIR/ODAR/ODA-Unit Member in good-standing is highly preferred and may offset some or all of the experience requirements.
Lean and/or Six Sigma trained; Black belt experience preferred.
Quality certification desirable, such as CQM, CQE, or related.
Knowledge, Skills and Abilities:
In-depth knowledge of FAA 14CFR Part 21 required.
In-depth understanding of the requirements of the AS9100 framework.
Knowledge of aircraft industry quality system standards and knowledge of manufacturing processes and related process controls.
Advanced math and statistics skills as they apply to quality assurance.
Working knowledge of statistical analysis tools.
In-depth knowledge in the administration of quality systems for both internal and suppliers.
Experience with risk management tools, including FMEA and risk cubes.
Good organization and time management skills.
Strong oral and written communication skills; ability to present findings to team members, management and support personnel.
Ability to independently generate presentations regarding quality assurance group activities and status, and present them to senior quality management, and development staff.
Good analytical and problem solving skills.
Interpersonal skills for interacting with project and task team members.
Good personal computer and business solutions software skills.
Ability to handle activities on multiple projects and tasks within the same or different accounts.
Strong priority skillset.
Ability to work independently.
Ability to work in a team environment, even when remote support is required.
Ability to deal with and manage change.
Ability to complete assigned responsibilities in a given timeframe within a given budget.
Thorough working knowledge of SPC, Lean and/or Six Sigma. ASQ Certified Quality Engineer, Certified Quality Manager or Six Sigma Black Belt.
Manager, Quality Control
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.
This position will be responsible for the management of the BLI QC group and all associated support functions, including contract laboratory activities, ensuring that all Microbiology, Chemical, Potency and Biochemical testing is performed according to FDA, Foreign MOH and Allergan requirements.
This individual will verify that the quality of drug substance product meets all Regulatory commitments, manage the product stability testing program, and manage all associated contract testing facilities.
The individual will collaborate with and effectively represent BLI Management and QC in meetings with internal and external partner groups.
This individual will represent QC during regulatory or internal inspections and responding to any observations.
The individual will be responsible to ensure appropriate training and development plans are in place for all employees in the QC group.
The individual will be responsible to ensure the QC departmental budgets and project expenditures are managed in manner which maximizes value to Allergan and meets the BMD budgeting targets.
The individual will be expected to champion, lead and participate in continuous improvement activities within the BLI facility, including method improvements/verifications/validations and transfers.
Knowledge, Skills and Abilities:
Demonstrated knowledge and experience with validating QC methods for protein analysis.
Working knowledge of regulatory compliance and Experience working in a GMP environment. Familiarity with process characterization and process validation is desired.
Demonstrated ability to manage, multi-task, delegate, and retain flexibility in a dynamic environment.
Well developed written and oral communication skills. Motivated to work in a team environment.
Consistently deliver on commitments and respond to customers' needs in a timely and courteous manner.
Demonstrated knowledge of the use of a continuous improvement methodology in a lab testing environment, desired but not essential.
Minimum Requirements and Education:
MS in Chemistry/Biochemistry or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry or a related Biological Science field with 5+ years of relevant industrial experience.
3-5 years of experience with people supervision working in a technical environment
Manager, Quality Control
Plans, coordinates, and directs quality control program designed to ensure continuous high quality work and materials consistent with established FAA standards by performing the following duties personally or through subordinate supervisors.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Develops and analyzes statistical data and specifications to determine present standards and establish proposed quality and reliability expectancy.
Based on FAA standards, formulates and maintains quality control objectives and coordinates objectives with A&P Mechanic's procedures to maximize safety and reliability which minimize costs.
Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and work.
Plans, promotes, and organizes training activities related to product quality and reliability.
Investigates customer complaints regarding quality.
Is able to meet the Station's attendance standards.
Is able to continually lift move/push 70lbs.
Must pass pre-employment drug test
RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's degree (B. A.) from four-year College or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
Ability to read, analyze, and interpret general business periodicals, FAA documentation, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
FAA Certification. Possess/maintain a valid driver's license and other FAA/Airport required identification/seals or authorizations. Accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to vibration. The employee occasionally works near moving mechanical parts; in high, precarious places; and in outside weather conditions and is occasionally exposed to fumes or airborne particles, extreme cold, extreme heat, and risk of electrical shock. The noise level in the work environment is usually quiet.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable
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