The Operational Area Quality Specialist will provide QA support of analytical laboratory operations. This role will review data clinical and commercial analytical, release and stability data, including deviations, in-process data, and other quality systems documentation as needed in support of product disposition.
Responsibilities include but are not limted to:
- Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
- Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
- Upload the vendor created protocols in QDocs and update all commercial stability-controlled documents in QDoccs including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
- Provide support to Clinical analytical data review as needed
- Support the day-to-day management of the analytical data from external CMO - Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
- Communicates proactively with internal and external partners and management.
- Assists department mgmt. with monthly/quarterly Quality System data review metrics and reporting
- Escalate critical and major finding to Quality management related to GXP Operational areas