Job Details
The Senior QA Specialist in QA Investigations/CAPA is a role with individual responsibilities, primarily focused on conducting technical quality compliance activities aligned with GxP regulations and internal SOPs. This subject matter expert ensures thorough investigation of deviations, determination of root causes, and implementation of appropriate corrective actions based on associated risks to processes, compliance, or SISPQ. Additionally, this individual oversees and communicates critical metrics concerning deviations and CAPAs. They also offer QA review and oversight of Trend Review Reports to detect interrelationships among process inputs and critical parameters, as well as to identify process shifts.
Responsibilities:
- Supervise and facilitate the prompt assessment, investigation, resolution, and follow-up of unforeseen incidents while identifying areas for continuous enhancement.
- Collaborate with subject matter experts to conduct comprehensive root cause analyses, evaluate impacts on SISPQ, and ensure appropriate Corrective/Preventive Actions are implemented.
- Establish appropriate ownership and timelines for CAPAs based on the risk associated with the incident or concern.
- Evaluate final supporting documentation to ensure completion and closure of CAPAs are satisfactory. Conduct effectiveness checks for CAPAs related to high-risk events.
- Communicate crucial metrics regarding deviations and CAPAs, leading the Investigation Review Board meetings.
- Offer oversight and insights for Trend Review Reporting and Lifecycle Review endeavors to pinpoint and tackle process shifts and patterns.
- Serve as the subject matter expert and trainer for the TrackWise Investigation/CAPA module.
- Compile and present quality metrics as needed to keep upper management informed about relevant trends and ongoing activities concerning investigations, CAPAs, etc.
Requirements:
- Minimum of 5 years experience GMP/Biopharmaceutical/Biotech Industry/FDA, 3-5 years specific QA hands on experience in a pharmaceutical environment, cell and gene therapy experience preferred.
- Bachelor s Degree in a technical or scientific discipline or equivalent
- Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
- Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, Investigations.
If this opportunity is of interest please reach out to me on ...@hartmannyoung.com