Senior QA Specialist
Princeton, NJ 08540
Sr. QA Specialist #1113
The Senior QA Specialist reviews the deviations, change controls and validation documents with minimal supervision. This role will be responsible for the review of deviations for manufacturing process deviations and out-of-specification results through the various phases of the process. This position participates in meetings related to deviations, CAPAs, and change controls and will prepare annual product review reports.
- Review batch record documentation for accuracy and completeness as per Regulatory guidelines, GMPs and company procedures.
- Maintain follow-up with the other internal departments and external clients to assure timely completion of records for final product release.
- Write deviation summary reports including references from FDA/PDA/Other standard guidance, and cGMP with minimal supervision
- Participate and conduct meetings with minimal supervision.
- Review validation protocols per FDA guidelines/company procedures with minimal supervision in a timely manner.
- Review validation reports per approved validation protocols with minimal supervision in a timely manner.
- Review Change Controls per company procedures in a timely manner with minimal supervision.
- Keep track of Key Performance Indicators associated with the review activities and report to supervision.
- Write and revise procedures associated with deviations and change controls with minimal supervision.
- Assist in the preparation of annual product review reports
- Perform procedures to complete finished product release and lot disposition.
- Bachelor’s Degree in related field
- Minimum of 3 years of relevant experience in the pharmaceutical industry
- Knowledge of GMP standards, Quality Systems, and Health Authority Regulations