QA Specialist I: Drive GMP Quality & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a QA Specialist I to ensure product quality and regulatory compliance. You will review batch records, disposition lots, and oversee deviation investigations and CAPAs.

You’ll contribute to cGMP compliance, SOP updates, and regulatory readiness while partnering with manufacturing, QC, and client teams. The role requires a Bachelor’s in a scientific field with 5–7 years in pharma/biotech, including 3+ years in QA operations; strong RCA, writing, and risk

Qualifications

• Bachelors in a science field with 5-7 years pharma/biotech experience, including 3+ years QA operations.
• Experience RCA, technical writing, and investigations.
• Knowledge of FDA regulations (21 CFR 210, 211, 820) and ICH guidelines.

Responsibilities

• Review batch documentation for release in compliance with cGMPs and SOPs.
• Approve master batch records and initiate GxP manufacturing activities.
• Oversee deviations/investigations and CAPAs; enforce timely completion and documentation.
• Review and approve investigations across Manufacturing and Quality Control.
• Provide guidance on complex investigations and CAPAs; support change controls.
• Coordinate change control reviews and monitor status; prepare management reports.
• Interface with clients to address documentation and compliance concerns.

Skills

Root Cause Analysis

Technical Writing

Quality Investigations

Risk Management

MS Office

Communication

Attention to Detail

IQ/OQ/PQ

Education

Bachelor's Degree in a relevant scientific discipline

ASQ Certification (preferred)

Tools

IQ/OQ/PQ

Job description

PCI Pharma Services in Bedford, NH seeks a QA Specialist I to ensure product quality and regulatory compliance. You will review batch records, disposition lots, and oversee deviation investigations and CAPAs.

You’ll contribute to cGMP compliance, SOP updates, and regulatory readiness while partnering with manufacturing, QC, and client teams. The role requires a Bachelor’s in a scientific field with 5–7 years in pharma/biotech, including 3+ years in QA operations; strong RCA, writing, and risk