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 .
...cards, Repairs & Maintenance Per trip incentive pay Flexible schedule Paid time off My MediRides is looking for Weekend drivers . If you are a kind and hard working individual that enjoys helping people then this role is for you!!! Responsibilities This...
...Medical Social Worker Home Health- $5,000 Sign-On Bonus!! Location: Corvallis, OR (territory includes surrounding areas, within a ~60-mile radius) Compensation: $40$50 per hour (commensurate with experience) Travel Required: Yes (valid drivers license, personal...
...CEO (Chief Executive Officer), Blockchain Experience Required, Silicon Valley, CA The CEO (Chief Executive Officer) will be part of this organization that aims to bring together the top 1% of intelligent people worldwide, providing them with an autonomous collaborative...
...dedicated and compassionate Certified Occupational Therapy assistant (COTA) to join our Hudson Valley team, to work with children and... ...patience/professionalism. Physical Requirements: Must be able to travel to and from assigned cases including but not limited to driving...
...Owner Operators Delivery Driver Diamond Expedited is currently looking for Independent Contractors (ICs) with Minivans or Cargo Vans to perform small package deliveries in the Grand Rapids area. What we have available: AM routes picking up locally at 5am finished...