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Qa Specialist Ii - Ops at PCI Pharma Services - ApplyBlast

Qa Specialist Ii - Ops

PCI Pharma Services

5 months ago

2.9 on Glassdoor

Bedford, NH

Onsite

Full Time

Senior

0 applicants

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About this role

A QA Specialist II at PCI Pharma Services ensures the quality and compliance of pharmaceutical products through rigorous batch record reviews, deviation investigations, and CAPA management. This role supports both late-stage clinical and commercial production by overseeing GxP programs, risk assessments, and document controls to maintain regulatory standards.

Responsibilities

Review batch documentation for clinical and commercial product release
Manage deviation investigations and approve corrective action plans
Oversee quality system procedures and specifications development
Facilitate change control reviews and risk assessment processes
Ensure site readiness for regulatory inspections

Skills

Qualifications

Bachelor's Degree in Biological Sciences or related field5-7 years of experience in pharmaceutical or biotech industry3+ years in QA Operations roleExperience with FDA regulations (21CFR Parts 210, 211, 820)ASQ certification preferred

About PCI Pharma Services

pci.com

Headquarters

Philadelphia, Pennsylvania, United States

Company Size

1001-5000 employees

View Profile

PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success.