QA Internal Operations Lead — GMP Compliance

pciservices; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a Supervisor, QA Internal Operations to lead a QA Operations team ensuring 7‑day on‑the‑floor QA oversight for clinical and commercial drug products. You will drive compliance with cGMP, support batch reviews, and partner with Manufacturing Operations, Visual Inspection, and Materials Management to resolve quality issues.

The role requires a Bachelor’s in a scientific field, 5+ years of pharma/biotech experience, and strong organizational and

Qualifications

• Bachelor's Degree in relevant scientific discipline.
• 5+ years pharmaceutical or biotech industry experience.
• 3+ years QA Operations role supporting late stage clinical/commercial production.
• ASQ certification preferred.
• Excellent organizational and communication skills.

Responsibilities

• Oversee QA support for daily cGMP manufacturing operations.
• Coordinate cross-functional teams to improve procedures for line clearances, labeling, packaging and material release.
• Support production scheduling by monitoring schedules and factors affecting them.
• Supervise labeling and disposition functions, including AQL sampling and inspection of final lots.
• Review and approve Blue Mountain documents and work orders.
• Conduct staff performance reviews and align goals to corporate initiatives.
• Ensure staff training is current and in good standing.
• Assist with batch record reviews and generation of CoAs.
• Support external client audits and regulatory inspections.

Education

Bachelor's Degree in relevant scientific discipline

5+ years pharmaceutical/biotech experience

3+ years QA Operations experience in late-stage prod

ASQ certification

Excellent communication & organizational skills

Tools

MS Word

MS Excel

Documentation systems

Job description

PCI Pharma Services in Bedford, NH seeks a Supervisor, QA Internal Operations to lead a QA Operations team ensuring 7‑day on‑the‑floor QA oversight for clinical and commercial drug products. You will drive compliance with cGMP, support batch reviews, and partner with Manufacturing Operations, Visual Inspection, and Materials Management to resolve quality issues.

The role requires a Bachelor’s in a scientific field, 5+ years of pharma/biotech experience, and strong organizational and