Stability QC Specialist — Data & Compliance Lead

PCI Pharma Services; Tennessee; On-site; USD 75,000 - 110,000; Full time

Job summary

PCI Pharma Services is seeking a QC Stability Specialist in Bedford, NH to lead stability workflows, author stability documentation, and coordinate testing with internal and external labs. This role supports QC data review, trending, and timely completion of stability testing within cGMP guidelines.

The ideal candidate will have a Bachelor’s degree in a scientific field with 3+ years of CGMP/lab experience, strong technical writing, and proficiency in MS Office.

Qualifications

• 3+ years of experience in a CGMP/laboratory environment
• 2+ years stability program experience
• Experience in a cGMP/laboratory setting
• Experience in a (CMO) contract manufacturing/development organization preferred
• Strong documentation and technical writing ability
• Attention to detail and cross-functional collaboration
• Proficient in Microsoft Office (Excel, PowerPoint) and data review

Responsibilities

• Coordinate daily activities for QC analysts and stability workflows
• Drive testing completion through influence without direct authority
• Support investigations and CAPAs to improve laboratory performance
• Interact with clients and provide status updates
• Perform data review, analysis and trending
• Author and revise stability reports and SOPs
• Ensure compliance with cGMP concepts and regulatory guidelines
• Contribute to process improvements and testing efficiencies
• Provide occasional advanced analysis and wet/physical chemistry support
• Assist audits and client walkthroughs

Skills

cGMP

data analysis

technical writing

communication

team collaboration

problem solving

MS Office

Education

Bachelor's degree in a scientific field

Tools

Excel

PowerPoint

Job description

PCI Pharma Services is seeking a QC Stability Specialist in Bedford, NH to lead stability workflows, author stability documentation, and coordinate testing with internal and external labs. This role supports QC data review, trending, and timely completion of stability testing within cGMP guidelines.

The ideal candidate will have a Bachelor’s degree in a scientific field with 3+ years of CGMP/lab experience, strong technical writing, and proficiency in MS Office.