Qc Stability Specialist

Position: QC STABILITY SPECIALIST
## QC STABILITY SPECIALIST Apply:
Bedford, NH, USA:
Full time:
Posted Yesterday:
JR119471

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
** Final date to receive applications:
** 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