This Document Control Associate position is responsible for the day-to-day functions required of the department. Provide updates to QA Team Lead on progress of personal objectives and bring forward any deficiencies or issues identified within the specific areas of responsibility.
Position Responsibilities: • Know the governing regulatory agencies and an understanding of the regulations for those agencies as related to Document Control. • Day-to-day functions include, but are not limited to: • Completion of release documents for the EU (Batch Release Protocols (BRPs) / Passbills) • Issuance and reconciliation of controlled documents according to production work schedules (batch records, Veeva Vault documents, logbooks) • Finalizing of controlled documents (batch records, Veeva Vault documents) • Promoting documents into an electronic system (batch records, Veeva Vault documents) • Typing of necessary documents • Revision of department policies, procedures and logbooks • Archival and scanning of completed batch records, raw material packets • Archival of logbooks, master documents and misc. records. • Filing • Retrieval of records from archives for manufacturing, complaints and inspections • Reconcile paperwork from manufacturing into Document Control files • Destruction of documents after reaching retention period • Back-up duty includes release of semi-finished goods, antigens, seeds and medias. • Promotes teamwork and promotes innovative thinking to continuously identify and implement improvements, while managing the workload, objectives, and individual development. • Exhibits strong communication skills to coordinate needs with production colleagues • Exhibits strong attention to detail and ability to perform tasks right first time. • Exhibits organizational skills necessary to manage projects and maintain collaboration and consistencies between sites. • Issue status reports to all departments as outlined in standard operating procedures (SOPs). • Ensure documents requested for regulatory inspections are provided in a timely manner. • Manages own time to guarantee through-put of documents to ensure there is not a backlog and make risk-based decisions without a team leader present • Cross-train in all aspects of Document Control functions • Participate in the on-call schedule for the department • Lifting of up to ~50 is required...Job Description Job Description The Maintenance Technician is responsible for installing, repairing and maintaining large industrial... ...all safety rules, policies and procedures required by Shared Hospital Services. # Remain current on equipment and repair procedures...
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