QC STABILITY SPECIALIST

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

## QC STABILITY SPECIALISTApply: Bedford, NH, USA: Full time: Posted Yesterday: JR119471Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.**Date Issued:**September 14, 2026**Application Deadline:**September 22, 2026**Wage Level:**Salary**JOB DESCRIPTION:****Position Title**: QC Stability Specialist**Location:** Bedford, New Hampshire**Department:** Quality Control**Reporting To:** Stability Manager/Supervisor**Responsible For (Staff):** NoThis position has primary responsibility for facilitation of PCI PHARMA SERVICES’s stability program including authoring stability protocols, set-down of samples, removal of samples from storage according to schedules, coordination of testing with internal/external laboratories, and collation of data for QA review. Also supporting activities related to the on-time completion of testing for QC stability samples as required per the applicable stability programs. Additional areas of responsibility include but are not limited to QC data review / trending and generation or reports.**ESSENTIAL DUTIES AND RESPONSIBILITIES:*** Coordinate daily activities for the QC analysts and other departments performing stability workflows, ensuring all activities are completed as required per the stability testing program.* Using influence strategies to drive testing completion without direct authority over testing groups.* Support laboratory investigations and deviations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).* Interact with clients both internal and external providing status updates.* Provide support in resolving technical QC issues.* Perform technical data review, data analysis, and trending.* Author(s) and Revise(s) technical documentation (e.g. Stability Reports, SOPs, forms, etc.) as required.* Implement and applies cGMP concepts in association with department specific responsibilities.* Actively engage in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies and workflows.* Drive testing efficiencies in order to reduced testing time and improve compliance.* Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.* Occasional and infrequent testing support with advanced analysis and wet/physical chemistry.* Supports audits, including laboratory walkthroughs with client and regulatory agencies.* Other duties, as needed**QUALIFICATIONS:****Required:*** ### Bachelor’s degree in a scientific field with 3 or more years’ experience in a CGMP / laboratory environment.* 3+ years of relevant experience in a cGMP organization* 2+ years stability program experience* Experience working in a cGMP/ laboratory required.* Experience working in a (CMO) contract manufacturing/development organization preferred.* Ability to work independently with minimal supervision and in compliance with cGMPs.* Scientific technical writing ability including authoring and revising SOPs or technical documents and reports.* Must have strong attention to detail as well as ability to work in a cross-functional team environment* Excellent organizational skills and the ability to work within a fast-paced environment* Must have proven logic and decision-making abilities, critical thinking skills.* Working knowledge of cGMP, ICH, USP, and global compendial regulations guidelines specifically how they pertain to stability programs.* Proficient in Microsoft Office, Excel, and PowerPoint.* Excellent communication and interpersonal skills are must.**Preferred:*** Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) desirable* Background in data trending desirable* Excellent interpersonal skills and the ability to communicate well both orally and in in writing* Ability to multi-task in a dynamic environment with changing priorities* Resilient, can quickly move forward despite challenges* A drive to achieve results for self and clients* Positive attitude and strong team, cross team collaboration* Honesty, integrity, respect and courtesy with leadership and peers