QA GMP Auditor (Large Molecule) – Direct Hire/Will Relo (RTP, NC)
Our client, a leading bioanalytical services contract research organization that serves the pharmaceutical and biotech industries, is actively recruiting for a quality driving GMP Auditor to join its growing quality team.
This is one of the fastest growing companies in the Triangle. It is a GMP and GLP laboratory, that focuses on assuring the consistency, quality and safety of all manufactured biologic products by adhering to Good Manufacturing Practice procedures and regulations.
This company seeks the best and the brightest for its Quality team and will pay excellent wage, including relo support, to attract and retain a star.
Key Things to Note:
- This GMP Quality Auditor will play a critical role in ensuring readiness for client and regulatory audits and inspections.
- Role will involve QA reviews for compliance with SOPs, methods, GMP regulations, etc. Seek candidate with thorough knowledge of GMP and GxP reg’s and high aptitude for learning company SOPS, methods, etc.
- The company provides support services for biomarkers, immunogenicity, pharmacokinetics (PK), flow cytometry, and cell-based assays. Quality/Audit experience in large molecule bioanalysis will be important.
- This is an emerging company with a collaborative work dynamic and a strong client service orientation. Seek team player who is a quick study and brings an unwavering commitment to excellence.
- Perform GMP Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
- Issue QA statements for reports as needed
- Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
- Assist in writing and reviewing QA standard operating procedures
- Positively impact the company through successful contributions, active participation and identification of compliance gaps
- Participate in document management activities
Targeted candidate will offer a BS in related science and 2+ years of experience working in a QC GMP lab, plus substantial experience in a QA GMP role. Experience working within a pharma, biotech and/or CRO setting will be important.
Other priorities include:
- Large molecule expertise
- Internal and/or external GMP auditing and inspection readiness experience
- Thorough knowledge of GxP regulations and practices
- QC GMP laboratory experience
- Excellent juggling skills, including ability to meet tight deadlines
- Strong oral and written communication skills, including compliant and clean documentation skills
- Keen eye for detail
- Proficiency in MS Excel and Word
This is an immediate need. Growth potential is enormous.
Please forward Word resume for prompt consideration.