QA Specialist I: GxP Compliance & Batch Release

PCI Pharma Services; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist I to join the Quality Assurance team in Bedford, NH. The role supports batch release, deviation investigations, CAPAs, and quality system oversight in a fast-paced pharmaceutical environment.

The ideal candidate has a strong background in QA investigations, cGMP, and regulatory knowledge, with 3+ years in QA operations. This on-site position offers opportunities to contribute to both clinical and commercial manufacturing.

Qualifications

• Experience performing RCA, technical writing, and working with quality related investigations.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• Knowledge of FDA regulations (i.e., 21 CFR Part 210, 211 & 820) and some experience with ICH.
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
• Bachelor’s Degree in a relevant scientific discipline with 5-7 years of pharmaceutical or biotech industry experience and 3+ years in a QA Operations role.
• Exceptional organizational skills and attention to detail.
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Excellent interpersonal and written communication skills.
• Proficiency in MS Office including Word, Excel, Access and Visio.
• Ability to work in a dynamic, fast-paced environment.
• Honesty, integrity, respect and courtesy with all colleagues.
• Creative with independent thinking and minimal supervision.
• Resilience through operational and organizational change.

Responsibilities

• Review batch documentation for release of internal and external products, ensuring cGMP and regulatory compliance.
• Review and approve master batch records for timely GMP manufacturing activities.
• Oversee deviations, investigations and CAPA programs.
• Approve investigations to support batch release and GMP compliance.
• Provide direction for complex investigations and CAPAs.
• Track quality system events and maintain documentation and metrics.
• Review and approve quality system procedures, specs and test methods.
• Approve CAPAs to prevent recurrence of deviations.
• Review Change Control documentation and assist with change controls.
• Provide status reports and participate in management review.
• Collaborate with internal and external customers to address quality and compliance issues promptly.
• Identify and propose quality process improvements and lead related projects.
• Act as QA representative on cross-functional teams (tech transfer, process validation, improvements).
• Coordinate change control review meetings and approval processes.
• Perform risk assessments to ensure compliance with internal and external guidelines.
• Provide training on department procedures and systems.
• Interface with clients to address documentation and compliance concerns.

Skills

RCA & investigations

Technical writing

Quality investigations

Lab/production equipment knowledge

IQ/OQ/PQ

FDA regulations knowledge

Risk management tools

MS Office proficiency

Communication skills

Decision making

Organizational skills

Education

Bachelor’s degree in a relevant scientific discipline

ASQ certification (preferred)

Tools

MS Word

MS Excel

MS Access

MS Visio

Job description

PCI Pharma Services is seeking a QA Specialist I to join the Quality Assurance team in Bedford, NH. The role supports batch release, deviation investigations, CAPAs, and quality system oversight in a fast-paced pharmaceutical environment.

The ideal candidate has a strong background in QA investigations, cGMP, and regulatory knowledge, with 3+ years in QA operations. This on-site position offers opportunities to contribute to both clinical and commercial manufacturing.