Compliance Specialist at PCI Pharma Services · Bedford, NH · Joined
PS
Compliance Specialist
PCI Pharma Services · Bedford, NH · Just now · 0 applicants
NewOn-siteFull-timeMiddle
Pay
Pay not listed
Workplace
On-site
Job type
Full-time
Level
Middle
Team: Engineering Compliance · Source: jobright · Posted by joined-scrapper
About the role
PCI Pharma Services seeks an Engineering Compliance Specialist to manage quality system records and support regulatory compliance across engineering, quality, and manufacturing. The role focuses on change controls, deviations, CAPA plans, SOP updates, and continuous improvement in a cGMP environment.
What you’ll do
Manage change controls
Lead deviations and CAPA plans
Update SOPs
Collaborate with engineering, quality, and manufacturing
Maintain regulatory compliance
Drive continuous improvement
What you’ll need
2+ years in GMP, ISO, and/or FDA-regulated environment
Strong technical writing for quality system documents
Investigation, root cause, and risk analysis in cGMP
Knowledge of regulatory requirements and best practices
Project management skills
Bachelor's degree in science or engineering preferred
Original job description
PCI Pharma Services is a biopharmaceutical services company supporting life-changing therapies and sterile fill-finish operations. The Engineering Compliance Specialist manages change controls, deviations, CAPA plans, and SOP updates while collaborating across engineering, quality, manufacturing, and other departments to maintain regulatory compliance and…