Quality & Validation Specialist — cGMP Compliance

Kelly; Wilson (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Kelly, in partnership with Johnson & Johnson, seeks a Quality Specialist to ensure regulatory and company policy compliance across cGMP, FDA/EMA guidelines, and internal procedures. The role covers QA oversight of commissioning/qualification, validation lifecycle, and technical documentation in a fast-paced manufacturing environment.

Responsibilities include developing validation plans, reviewing URS/IQ/OQ/PQ docs, and supporting deviations, CAPAs, and change controls.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline is required.
• Minimum of two years in a regulated industry.
• At least one year in Quality Assurance within biotherapeutic/pharma.
• Knowledge of GMP, FDA/EMA/ICH guidance and ISPE Baseline Guides.
• Hands-on qualification and validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ).
• Experience with cleaning and process validation.
• Strong technical writing for validation and quality documents.
• Ability to collaborate with cross-functional teams and handle multiple priorities.

Responsibilities

• Develop and maintain the site validation program in line with regulatory and corporate requirements.
• Collaborate with qualification teams across design, construction, qualification and project implementation phases.
• Review and approve commissioning/qualification docs and SOPs.
• Provide QA oversight of C&Q, CSV and validation activities for compliance.
• Support development of C&Q/validation plans aligned to timelines.
• Review system impact assessments and understand equipment categorization.
• Ensure adherence to quality standards and change controls related to validation.

Skills

Regulated industry experience

Quality Assurance

cGMP knowledge

Technical writing

Cross-functional collaboration

Independent work

Multitasking

Problem solving

Education

Bachelor's degree in a scientific or engineering discipline

Tools

GAMP 5

ISPE Baseline Guides

URS/FAT/SAT/IQ/OQ/PQ processes

Job description

Kelly, in partnership with Johnson & Johnson, seeks a Quality Specialist to ensure regulatory and company policy compliance across cGMP, FDA/EMA guidelines, and internal procedures. The role covers QA oversight of commissioning/qualification, validation lifecycle, and technical documentation in a fast-paced manufacturing environment.

Responsibilities include developing validation plans, reviewing URS/IQ/OQ/PQ docs, and supporting deviations, CAPAs, and change controls.