Sr. QA Specialist
Responsibilities of the Sr. QA Specialist:
- Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
- Review and approve batch records.
- Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
- Review and approve preventative maintenance, calibration, and work order documentation.
- Review, assist in the investigation of, and approve environmental excursions.
- Provide on-the-floor QA support for manufacturing activities.
- Represent Quality Assurance on project teams and in meetings.
Requirements of the Sr. QA Specialist:
- BS required, MS preferred in a scientific/technical discipline with 10+ years of experience in a QA position within the biological and/or pharmaceutical industry.
- Ability to apply GMP regulations and international guidelines to all aspects of the position.
- Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy.
- Paid time off
- Medical and dental insurance
- 401K Match
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.