Sr. QA Documentation Specialist
Responsibilities of the Sr. QA Documentation Specialist:
- Build, manage, train and develop the QA Validation team.
- Develop the Master Validation Plan and individual validation plans, specifications, protocols (IQ, OQ, PQ), and validation reports to ensure project timelines are met.
- Oversee the operation, maintenance, and decommissioning of equipment and software, as applicable.
- Responsible for the Quality oversight of the validation program, including the validation of new equipment and software, periodic reviews, re-validation, and continuous improvement.
- Manage inspection readiness for site licensing.
- Incorporate risk management principles into the validation program.
- Assure the validation requirements meet all applicable global Health Authority requirements and industry regulations, and assure validation documents are executed to meet these requirements.
- Oversee investigations and actions related to validation deviations.
- Analyze appropriate metrics and KPI, providing recommendations to senior management regarding quality related risks.
- Oversee inspection and/or audit readiness for validation, leading discussions during Health Authority Inspections and participating in responses to and CAPA for regulatory findings.
Requirements of the Sr. QA Documentation Specialist:
- BS Degree in Life Sciences preferred.
- 5+ years of related experience.
- Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
- Working knowledge of current Good Laboratory Practices (GLP – 21 CFR Part58), Good Manufacturing Practices (cGMP – 21 CFR Part 210/211), and Electronic Records; Electronic Signatures (21 CFR Part 11).
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.