Stability Program Lead — QC & Data Insights

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a QC Stability Specialist to lead the stability program, author stability protocols, and coordinate sample testing with internal/external labs. You will perform data reviews, trending, and generate reports to support QA sign-off, while applying cGMP principles and driving continuous improvement across the stability function.

Excellent written communication and collaboration across cross-functional teams are required to meet testing timelines and

Qualifications

• Bachelor’s degree in a scientific field with 3+ years CGMP/lab experience.
• 3+ years in a CGMP organization with stability program experience.
• Experience in a (CMO) contract manufacturing/development organization preferred.
• Strong attention to detail and ability to work in a cross-functional team environment.
• Proficient in Microsoft Office, Excel, and PowerPoint.

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 CAPAs to improve 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 and revise technical documentation (e.g. Stability Reports, SOPs, forms).
• Implement and apply cGMP concepts in relation to stability program responsibilities.
• Engage in continuous improvement for stability processes and workflows.

Skills

CGMP knowledge

Data analysis

Technical writing

Attention to detail

Education

Bachelor’s degree in a scientific field

Tools

HPLC

GC

FTIR

UV

KF

MS Office

Job description

PCI Pharma Services in Bedford, NH seeks a QC Stability Specialist to lead the stability program, author stability protocols, and coordinate sample testing with internal/external labs. You will perform data reviews, trending, and generate reports to support QA sign-off, while applying cGMP principles and driving continuous improvement across the stability function.

Excellent written communication and collaboration across cross-functional teams are required to meet testing timelines and