Curia is looking to hire a Quality Assurance Specialist I to maintain Quality databases and provide on-the-floor QA presence and oversight to manufacturing operations. The role involves identifying compliance risks, managing deviations, and ensuring adherence to cGMPs and internal procedures.
Requirements
- Minimum 0-3 years’ experience in a cGMP and FDA-regulated industry
- Prior experience in a GMP regulated environment preferred.
Responsibilities
- Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files
- Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
- Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
- Assist in performing investigations
- Perform and/or assist with internal audits, weekly walkthroughs, and/or external audits
- Perform QA visual inspection activities associated with clinical and commercial drug product
- Develop and/or maintain Quality System metrics for management review
Other
- Bachelor’s degree in Life Science or related field. Directly related experience in a GMP environment may augment degree requirements.
- Solicit feedback from various departments for operational improvement
- With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
- All interested applicants must apply online.
