QA Specialist I — Drive GMP Quality & CAPA Impact

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QA Specialist I to join the Quality Assurance department. The role focuses on batch record review, lot disposition, CAPA oversight, and deviations with escalation for investigations.

You will support both clinical and commercial product quality and ensure adherence to cGMPs and regulatory standards. The position requires experience with QA investigations, regulatory knowledge (FDA 21 CFR) and risk management tools, plus strong documentation and

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 (21 CFR Part 210, 211 & 820) and ICH.
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
• Bachelor's Degree in a relevant scientific discipline preferred with 5-7 years pharmaceutical or biotech industry experience with 3+ years of QA Operations role.
• Exceptional organizational skills and attention to detail.
• Ability to make risk based decisions and resolve issues with minimal guidance.
• Excellent interpersonal skills and ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, Excel, Access and Visio.
• Excellent verbal and written communication skills required.

Responsibilities

• Review batch documentation for release and ensure compliance with cGMPs and site SOPs.
• Review and approve master batch records for timely initiation of GxP manufacturing activities.
• Oversee deviation/investigation and CAPA programs and track progress.
• Review investigations across Manufacturing and Quality Control and approve actions.
• Provide direction for complex investigations and CAPAs.
• Ensure timely execution and documentation of quality events and CAPAs.
• Develop and approve quality system procedures and test methods.
• Monitor change control documentation and approvals.
• Track investigations and change controls with status reports for management review.
• Collaborate with internal/external customers on quality/compliance matters.
• Lead quality process improvements and communicate status to management.
• Serve as QA representative on cross-functional teams (tech transfer, process validation).
• Coordinate change control review meetings and approvals.
• Perform risk assessments to comply with procedures and guidelines.
• Provide training on department procedures and systems.
• Interface with clients to address documentation and compliance concerns.

Skills

RCA investigations

IQ/OQ/PQ

FDA regulations

Risk management tools

MS Office

Communication

Documentation writing

Education

Bachelor's Degree in science

Tools

MS Word

MS Excel

MS Access

MS Visio

Job description

PCI Pharma Services in Bedford, NH is seeking a QA Specialist I to join the Quality Assurance department. The role focuses on batch record review, lot disposition, CAPA oversight, and deviations with escalation for investigations.

You will support both clinical and commercial product quality and ensure adherence to cGMPs and regulatory standards. The position requires experience with QA investigations, regulatory knowledge (FDA 21 CFR) and risk management tools, plus strong documentation and