Quality Assurance Batch Admin at The Ritedose Corporation in Columbia, South Carolina

Job Description:

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