Quality Stability Specialist - Data-Driven QC & CGMP Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 80,000 - 112,000; Full time

Job summary

PCI Pharma Services seeks a QC Stability Specialist to manage the stability program at our Bedford, NH site. You will author stability protocols, coordinate testing with internal/external laboratories, review data, and generate stability reports to support QA. The role requires CGMP experience, data analysis skills, and strong technical writing.

Join a team focused on timely testing, continuous improvement, and client communication to ensure regulatory compliance across stability activities.

Qualifications

• Bachelor’s degree in a scientific field and 3+ years in a CGMP/lab environment.
• 3+ years stability program experience.
• Experience in a CGMP/CMO environment.
• Strong technical writing ability including authoring/revising SOPs or technical documents.

Responsibilities

• Coordinate daily activities for stability workflows and ensure tasks are completed per protocol.
• Review data, perform trending analysis, and participate in QA reviews.
• Author and revise stability reports, SOPs, and related forms.
• Support CAPAs and investigations to improve laboratory performance.
• Assist audits and client regulatory walkthroughs as needed.

Job description

PCI Pharma Services seeks a QC Stability Specialist to manage the stability program at our Bedford, NH site. You will author stability protocols, coordinate testing with internal/external laboratories, review data, and generate stability reports to support QA. The role requires CGMP experience, data analysis skills, and strong technical writing.

Join a team focused on timely testing, continuous improvement, and client communication to ensure regulatory compliance across stability activities.