Job Title: C&Q Quality Assurance Specialist
Location: North Carolina, USA
Work Type: 100% Onsite
Position Type: Contract
ProQuality Network is seeking a Commissioning & Qualification (C&Q) Quality Assurance Specialist to support a new biologics manufacturing facility. This role is responsible for ensuring regulatory compliance and adherence to company quality policies throughout project design and startup. The specialist will collaborate with cross-functional teams to execute and maintain the highest standards of quality during C&Q activities across equipment, utilities, and facility systems.
Key Responsibilities:Ensure compliance with cGMP , FDA , EMA , ICH , and ISPE Baseline Guidelines .
Support commissioning, qualification, and validation (C&Q) activities for equipment, utilities, and facilities.
Author, review, and execute C&Q lifecycle documentation , including URS , FAT , SAT , IQ , OQ , and PQ .
Conduct risk assessments and apply risk-based approaches to qualification and validation processes.
Act as Subject Matter Expert (SME) for microbiology laboratory equipment and chemical/bioassay validation.
Provide technical expertise for cleaning validation and process validation activities.
Collaborate with engineering, quality, operations, and validation teams to ensure compliance with best practices and project objectives.
Bachelor's degree in a scientific or engineering discipline .
Minimum 4 years of experience in the biopharmaceutical or pharmaceutical industry with direct C&Q experience.
Strong knowledge of GMP , validation lifecycle , and ISPE guidelines , including GAMP 5 .
Hands-on experience with all phases of qualification/validation documentation (URS, FAT, SAT, IQ, OQ, PQ).
Proficiency in technical writing for validation and quality documents.
Solid understanding of risk management methodologies , such as FMEA and HACCP .
Excellent communication and interpersonal collaboration skills.
Experience with utilities and process equipment , including:
WFI (Water for Injection)
Clean steam
SIP/CIP systems
Bioreactors
Chromatography systems
Demonstrated experience in C&Q strategy development and facility startup support .
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