Quality Assurance Specialist, C&Q & Validation

JobDiva, Inc.; Wilson (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson is seeking a Quality Assurance/Validation professional to ensure the site validation program adheres to GMP, FDA, EMA, and internal Master Plans. You will collaborate with QA, engineering, validation, and manufacturing teams to review URS, IQ, OQ, PQ protocols and associated reports, ensuring compliant documentation and cross-functional alignment.

The role requires 2–4 years in biotherapeutic/pharmaceutical validation, strong cGMP knowledge, and excellent technical writing and

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required.
• 2-4 years of experience in biotherapeutic/pharmaceutical industry with GMP qualification/validation knowledge.
• Hands-on experience with URS, IQ, OQ, PQ; quality system familiarity (SOPs, WIs).
• Strong understanding of cGMP, FDA, EMA, ICH guidelines; ISPE Baseline Guides.

Responsibilities

• Ensure site validation program complies with regulatory and corporate requirements and Master Plans.
• Collaborate with QA, engineering, validation, and manufacturing to address quality issues.
• Review and approve validation documentation (URS, IQ, OQ, PQ) and final reports.
• Provide QA oversight for C&Q/CSV activities and deviations, CAPAs, and change controls.
• Support development and implementation of C&Q and validation plans with respect to timelines and deliverables.
• Perform QA reviews of system impact assessments and equipment categorization.
• Ensure compliance with SOPs, work instructions, and quality policies.

Skills

GxP compliance

QA oversight

Regulatory knowledge

Validation lifecycle

Technical writing

Cross-functional collaboration

Communication

Documentation review

Risk-based approach

Education

Bachelor's degree in a scientific or engineering discipline

Job description

Johnson & Johnson is seeking a Quality Assurance/Validation professional to ensure the site validation program adheres to GMP, FDA, EMA, and internal Master Plans. You will collaborate with QA, engineering, validation, and manufacturing teams to review URS, IQ, OQ, PQ protocols and associated reports, ensuring compliant documentation and cross-functional alignment.

The role requires 2–4 years in biotherapeutic/pharmaceutical validation, strong cGMP knowledge, and excellent technical writing and