Senior QA Analyst – C&Q & Validation (Biopharma)

The Fountain Group; Wilson (NC); On-site; USD 69,000 - 79,000; Full time

Job summary

The Fountain Group is seeking a Quality Assurance Analyst III in Wilson, NC to provide QA oversight for commissioning, qualification and validation in a biotherapeutic/pharmaceutical manufacturing environment. You will collaborate with Engineering, Validation, and Operations to ensure regulatory compliance and quality, supporting documentation and QA reviews.

The role emphasizes review/approval of URS, FAT, IQ, OQ, PQ, and related reports, as well as CAPA, deviations, and change controls across

Qualifications

• Bachelor’s Degree in a scientific or engineering discipline.
• 2–4 years of experience in biotherapeutic/pharmaceutical industry.
• Experience with GMP commissioning, qualification, and validation.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines.
• Knowledge of validation lifecycle: URS, FAT, SAT, IQ, OQ, PQ.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Ensure the site validation program is developed and maintained in compliance with regulatory and site requirements.
• Represent Quality Assurance throughout requirement development, design review, construction, commissioning, qualification, and project implementation activities.
• Review and approve commissioning and qualification documentation, including URS, FAT, SAT, IQ, OQ, and PQ protocols and reports.
• Review and approve validation protocols and reports related to analytical, cleaning, process, and other validation activities.
• Provide QA oversight of C&Q, CSV, and validation execution to ensure GMP compliance.
• Collaborate with cross-functional teams to address quality and compliance issues.

Skills

C&Q / CQV

GMP Validation & Qualification

URS / FAT / SAT / IQ / OQ / PQ

Quality Systems – Deviations, CAPA &  

Education

Bachelor’s Degree in a scientific or engineering discipline

Job description

The Fountain Group is seeking a Quality Assurance Analyst III in Wilson, NC to provide QA oversight for commissioning, qualification and validation in a biotherapeutic/pharmaceutical manufacturing environment. You will collaborate with Engineering, Validation, and Operations to ensure regulatory compliance and quality, supporting documentation and QA reviews.

The role emphasizes review/approval of URS, FAT, IQ, OQ, PQ, and related reports, as well as CAPA, deviations, and change controls across