QC STABILITY SPECIALIST

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Bedford, NH, is seeking a QC Stability Specialist to lead stability activities within the Quality Control department. You will author stability protocols, coordinate sample set-downs, and manage testing schedules with internal and external labs to ensure timely data delivery.

The role requires a bachelor's degree in a scientific field with CGMP experience and 3+ years in stability programs, plus strong data analysis and technical writing skills.

Qualifications

• Bachelor's degree in a scientific field with CGMP experience required.
• 3+ years of CGMP/laboratory experience in a regulated environment.
• Experience with stability programs and data review.
• Strong written and verbal communication; ability to document and report.
• Proficient in MS Office; willingness to learn lab software.

Responsibilities

• Coordinate daily activities for the QC analysts and stability workflows.
• Perform data review, trend analysis, and support CAPAs to improve lab performance.
• Author and revise stability reports and SOPs as needed.
• Support audits and client communications; ensure testing timelines are met.
• Maintain alignment with cGMP/ICH/USP guidelines and continuous improvement.

Skills

Detail-oriented

Communication skills

Independent worker

Data analysis

Problem solving

Education

Bachelor's degree in a scientific field with 3+ years CGMP experience

Tools

HPLC

GC

FTIR

UV

KF

Job description

Life 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): No

This 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

#LI-RS1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.