Senior C&Q QA Specialist – Biotherapeutics

Biopharma Asia; Wilson (NC); On-site; USD 115,000 - 145,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina is seeking a Senior QA Specialist - C&Q to lead quality oversight across the C&Q and validation lifecycle for our new Biotherapeutics Manufacturing facility.

You will ensure GMP compliance, review URS/IQ/OQ/PQ documents, manage risk assessments and support regulatory readiness, while collaborating with cross-functional teams to deliver a compliant, state-of-the-art manufacturing site.

Qualifications

• Bachelor's degree in a scientific or engineering discipline with relevant QA/validation experience.
• Hands-on experience with qualification/validation lifecycle (URS, CARA, FAT, SAT, IQ/OQ/PQ).
• Strong knowledge of cGMP and global regulatory guidelines (FDA/EMA/ICH).

Responsibilities

• QA oversight of C&Q and validation activities across the project lifecycle.
• Review URS, FAT/SAT, IQ/OQ/PQ protocols and reports for compliance.
• Support site contamination control strategy and sterile processing qualifications.
• Ensure data integrity and adherence to good documentation practices.

Skills

QA oversight

Validation

cGMP

Regulatory knowledge

Education

Bachelor's degree in science or engineering

Tools

CSV/CSA software

Job description

Johnson & Johnson in Wilson, North Carolina is seeking a Senior QA Specialist - C&Q to lead quality oversight across the C&Q and validation lifecycle for our new Biotherapeutics Manufacturing facility.

You will ensure GMP compliance, review URS/IQ/OQ/PQ documents, manage risk assessments and support regulatory readiness, while collaborating with cross-functional teams to deliver a compliant, state-of-the-art manufacturing site.