Posted in Manufacturing 30+ days ago.
Type: Full-Time
Location: Columbia, South Carolina
The Quality Assurance Batch Administrator is responsible for supporting the administration of the Batch Record management process flow throughout its lifecycle. This responsibility includes tracking of issuance, receipt and reconciliation of three distinct lifecycles: Execution, Review, and Archival. Additionally, this position will track and facilitate corrections required by all departments to ensure batch metrics are being recorded accurately. Additional responsibilities as needed will include document scanning, logbook tracking, management of offsite storage location changes / retention, and QA Support as defined in the applicable SOPs.
Responsibilities:
Provide support for batch record lifecycle management to achieve a metric of NMT 15 days (start of QC testing to batch release)
Reconcile and track the progress of issued cGMP documents to achieve a metric of NMT 3 days (completion of execution to QA receipt)
Facilitate documentation corrections by department to achieve a metric of NMT 2 days (identification to completion)
Maintain the batch record tracking database and report trends of issues monthly (department/personnel)
Sign out / in batch record sections and logbooks
Coordinate location tracking for off-site document storage
Maintain office hours
Reassemble batch record documentation as needed
Scan QMS documentation as needed
Follow TRC SOPs, safety and health guidelines and cGMP guidelines
Perform other tasks as directed by management
High School Diploma or GED with one-year relevant experience
Understanding of cGMP documentation requirements
Proficient with current Microsoft Office word processing and database software
A high level of integrity and attention to detail
Strong interpersonal skills and ability to communicate effectively
Sam's Club
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AT&T
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AT&T
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