Stability QC Specialist — Drive Data-Driven Pharma Quality

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

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.