Senior QA Specialist: Elevate GMP Quality for Therapies

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 75,000 - 110,000; Full time

Job summary

PCI Pharma Services seeks a QA Specialist I to ensure product quality and regulatory compliance. You will review batch records, oversee deviations and CAPAs, and support quality systems across clinical and commercial production.

The role emphasizes cross-functional collaboration and timely quality decision-making. Ideal candidates have 5–7 years in pharma with QA operations experience, strong regulatory knowledge, and proficiency in risk assessment and document control.

Qualifications

• Minimum 5–7 years in pharmaceutical or biotech industry.
• At least 3+ years in a QA Operations role supporting late-stage clinical or commercial production.
• Strong knowledge of FDA regulations (21CFR Parts 210, 211, 820) and ICH guidelines.
• Experience with deviation investigations, CAPA, and change control processes.

Responsibilities

• Review batch documentation for release in compliance with cGMPs and regulatory requirements.
• Oversee deviation investigations, CAPA creation, tracking, and closure.
• Review and approve master batch records to initiate GMP activities.
• Provide guidance on complex investigations and quality systems improvements.
• Interface with internal/external customers on quality and compliance concerns.

Skills

RCA

Technical writing

QA investigations

Risk management

Education

Bachelor’s degree in science

Tools

MS Office Suite

FMEA/HACCP/PHA

Job description

PCI Pharma Services seeks a QA Specialist I to ensure product quality and regulatory compliance. You will review batch records, oversee deviations and CAPAs, and support quality systems across clinical and commercial production.

The role emphasizes cross-functional collaboration and timely quality decision-making. Ideal candidates have 5–7 years in pharma with QA operations experience, strong regulatory knowledge, and proficiency in risk assessment and document control.