Quality Assurance Specialist

Tekprosol; Princeton (NJ); Hybrid; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Tekprosol in Princeton, NJ, seeks a Quality Assurance Specialist to provide QA and regulatory support across pharma, biotech and CROs, ensuring GxP compliance in GMP, GLP, GCP, GDP environments.

The role includes internal audits, CAPA oversight, and eTMF audit responses, with exposure to viral vector processes, aseptic operations, and complex cell-based systems. Travel across the U.S. may be required.

Qualifikationen

• Master's degree required in Science, Technology, Business Administration, or Engineering.
• Experience in Pharmaceutical, Biotech, and CRO industries with GxP compliance.
• Audit management, CAPA oversight, and eTMF audit responses.

Aufgaben

• Provide QA and regulatory support across Pharmaceutical, Biotech and CRO industries.
• Ensure compliance with GxP (GMP, GLP, GCP, GDP) regulations.
• Manage internal audits, CAPA oversight, and eTMF audit responses.
• Develop and monitor data-driven quality metrics and improvements.

Kenntnisse

Quality Assurance Specialist

Ausbildung

Master's degree (Science/Technology/Business/Engineering)

Jobbeschreibung

Provide Quality Assurance and regulatorysupport across Pharmaceutical, Biotech and CRO industries, Ensure compliancewith GxP (GMP, GLP, GCP, GDP) regulations, Internal Audit management, CAPAoversight, and eTMF audit responses. Support GMP biologics manufacturing withexposure to viral vector processes, aseptic operations and complex cell-basedsystems. Develop and support audit programs, monitor compliance metrics andimplement data-driven process improvements in alignment with FDA, EMA, ISO andICH standards, Cross-functional collaboration. Master'sdegree in Science, Technology, Business Administration, or Engineering (Any) isrequired. Work location: Princeton, NJ and various unanticipated locationsthroughout the U.S.

Skills & Keywords

Quality Assurance Specialist