Document Control Job Description Sample
JLM is seeking a document control coordinator to join the document control team in providing administrative and technical support. This position works in a fast paced environment that is committed to detailed and organized systems.
Duties and responsibilities include but are not limited to the following:
- Provide technical and administrative support
- Prepare, process, log, and file incoming and outgoing project documents in Prolog
- Input and retrieve electronic files upon request
- Maintain project document filing system in accordance with established procedures
- Assist in project wide compliance with document control procedures
- Create and maintain document tracking logs
- Control and track the generation and distribution of electronic data
- Perform quality assurance on incoming and outgoing project documents
- Assist in training staff on document control procedures and requirements
- Work on Document Control tasks with minimal supervision when necessary
- Assist in related tasks as requested by Document Control Manager
- Proficient in Microsoft Suite programs
- Knowledge of construction documents including but not limited to drawings, specifications, change orders, RFI’s, submittals, etc.
- Must be able to follow established Project Document Control procedures
- Must be able to work both independently and under Document Control Manager
- Must be able to maintain a professional and cooperative attitude with all team members
- Must be able to work efficiently in a high stress environment
- Must be able to prioritize conflicting needs and handle matters expeditiously
JLM Strategic is an Affirmative Action/Equal Opportunity Employer. We consider qualified applicants for employment without regard to race, religion, color, national origin, ancestry, age, sex, gender, gender identity, gender expression, sexual orientation, genetic information, medical condition, disability, marital status, or protected veteran status.
Document Control Support 1
Document Control Specialist
- Develop, implement and maintain comprehensive record retention systems, policies and procedures
- Implement electronic file system
- Ensure accuracy, quality and integrity of all Company documents
- Ensure easy and efficient retrieval of documents
- Ensure that obsolete documentation is removed from distribution and is appropriately archived.
- Responsible for execution of all Document Change Orders in support of manufacturing, engineering and other departments, as necessary.
- Provide training for all employees on the Document Change Order process.
- Organize and maintain Design History Files from inception through archival.
- Enter data into various Microsoft Access databases.
- Maintain Master Part Number, Item Master and Document Index.
- Issue Lab Notebooks.
- Maintain all Training Files for the company.
- Perform other TransMedics job-related tasks and duties, as assigned.
Minimum of 3-5 years experience in Documentation Control role.
- A working knowledge and/or experience in the following areas:
- Working knowledge of QMS systems
- Experience working with various CAD files (AutoCAD, PRO-E, Orcad, SolidWorks).
- Experience working with Microsoft Office, Excel and Adobe documentation software.
- Experience maintaining Microsoft Access databases
- Creation of Adobe PDF control documentation
- Organizational and communication skills enabling accurate and detailed change order processing
- Team player with excellent verbal and written skills and attention to detail
- Experience working with an MRP interfacing system
- Experience working in a fast-paced environment as part of a cross-functional team
- Demonstrated track record working with limited direction to produce high quality work
- Proven Ability to provide logical, in-depth analysis of a problem or situation
Document Control Technician II
Document Management Analyst / Inventory Control Clerk
Associate, QA Document Control
Location: Menlo Park, California
Reporting to: Senior Manager, R&D Quality
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created. This role will report to the Senior Manager, Document Control, located in Menlo Park, CA (US) and will be responsible for processing Quality Assurance and other essential documents via the use of the company’s Electronic Document Management System (EDMS), MasterControl.
This position reports to the Senior Manager, R&D Quality, who is responsible for the management and oversight of the R&D Quality functions such as Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Good Laboratory Practices (GLP).
The Document Control Associate is expected to have a working knowledge of FDA and EU regulations concerning Good x Practices (GxP) in order to ensure compliance to quality standards for documentation change control and records management. The ideal candidate will have experience in using Master Control.
- Assist in the management of document and record workflows within the EDMS
- As required, scan, index and upload documents and records in to EDMS
- Assist in training and support of EDMS end users
- Assist in the development of training modules and qualification curriculums in the LMS
- Assist in the assignment of training curriculums
- Assist in the maintenance of electronic and/or hard-copy archives for applicable GxP records
SKILLS AND ABILITIES:
- A minimum of three years’ experience working within a GxP regulated environment.
- Prior experience working within a EDMS required
- Experience using a Learning Management System (LMS) required
- Strong communication skills (written and verbal).
- Customer service skills.
- Practical understanding of documents and records used within the Pharmaceutical industry.
- Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.
- Bachelor’s Degree in a life sciences related field preferred
- A minimum of 3 years of Quality Assurance, Document Control, Records Management and Archiving experience in a biotech or pharmaceutical company preferred.
- Experience with EDMS workflows required.
- Experience using a Learning Management System (LMS) desired.
- Proficient in pertinent software & tools.
- Must be knowledgeable of industry documentation types and Good Documentation Practices (GDP).
Document Control And Training Specialist 1
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