DOCUMENTATION COORDINATOR Job at Fresenius Kabi
Job Summary
POSITION SUMMARY
The Documentation Coordinator is responsible for the data processing of Change Notifications (CN) via Documentum, Document Change Requests (DCR), coordination of all controlled document implementation, update of SOP binder sets, control of document archival, and controlled document/logbook issuance, tracking, and reconciliation.
The individual in the position is responsible to communicate and coordinate with various departments to ensure accurate approvals of documentation in Documentum as well as manual routing such as DCRs. This position works closely with the Sr. Documentation Specialist and the Central File Clerk to ensure the controlled documents required for the production of injectable drug products are implemented, issued, tracked, and reconciled in compliance with cGMP and SOP.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.
- Coordinate and process CNs within Documentum and DCRs at the Production Unit level.
- Coordinates document’s early implementation (SOP) and updating of controlled binder sets
- Works directly with the IT Support Team to ensure cGMP/quality data is managed according to Documentum functions.
- Assures archives are orderly, complete, accurate and readily available for inspection.
- Assures proper organization, housekeeping, and security of Document Control areas at all times.
- Works with Compliance management Team on records and reports that are subject to FDA/cGMP inspection as needed.
- Coordinates issuance and reconciliation of controlled laboratory documents.
- Coordinates issuance of Production Batch Records.
- Maintains and issues Production Unit Log Books and ensures the logbooks are in compliance with all applicable procedures prior to being archived.
- Maintains tracking tools for log books and archived documents, ensuring accurate and complete records.
- Provides input on preparation and writing of SOPs for Document Control. Assists in the revision/update of procedures.
- Assists the Sr. Documentation Specialist with Documentum Training of Site personnel.
- Assists the Sr. Documentation Specialist with shipment and retrieval of documents to/from the off-site storage vendor.
- Performs other duties as assigned by the Documentation Manager or Director of Plant Quality Assurance.
REQUIREMENTS
- A High School diploma is required with an Associate’s Degree preferred. 1-3 years’ experience preferred.
- Working Knowledge of cGMPs and related Quality System processes is required.
- Position requires individual with high degree of accuracy and attention to detail.
- Good interpersonal and communication skills are required.
- Good organizational skills are required.
- Working knowledge of Microsoft Excel, Microsoft Access, Microsoft Word, and Documentum is highly desirable.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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