Title: C&Q Quality Assurance Specialist

Location: North Carolina, USA

Work Type: 100% Onsite

Contract Position with ProQuality Network for a Client in the Pharmaceutical & Medical Technology Industry

Summary

ProQuality Network is seeking a C&Q Quality Assurance Specialist to support the commissioning, qualification, and validation (C&Q) activities for a new manufacturing facility focused on innovative biologic medicines. This role ensures compliance with regulatory requirements and company policies during project design and operational start-up. The specialist will collaborate with cross-functional teams to maintain the highest quality standards.

Key Responsibilities

• Ensure compliance with cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides.
• Support commissioning, qualification, and validation (C&Q) activities for equipment, utilities, and facilities.
• Execute and review C&Q lifecycle documentation (URS, FAT, SAT, IQ, OQ, PQ).
• Perform risk assessments and apply risk-based approaches to qualification and validation.
• Serve as a Subject Matter Expert (SME) for microbiology laboratory equipment, chemical, and bioassay processes.
• Provide technical expertise on cleaning and process validation.Collaborate with cross-functional teams to ensure adherence to industry best practices.

Requirements

🎓 Bachelor’s degree in a scientific or engineering discipline.

• Minimum 4 years of experience in the biological and/or pharmaceutical industry with C&Q expertise.
• Strong knowledge of GMP processes, validation lifecycle, and ISPE guidelines (including GAMP 5).
• Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ).
• Proficiency in technical writing for validation and quality documents.
• Expertise in risk management methodologies (FMEA, HACCP).
• Strong communication and collaboration skills.

Preferred Qualifications (Nice-to-Have)

• Knowledge of utilities and process equipment (e.g., WFI, clean steam, SIP/CIP, bioreactors, chromatography systems).
• Experience in developing C&Q strategies and supporting start-ups.

If you meet the qualifications and are ready for an exciting opportunity, apply today with your updated resume using the link inside the job description!