QC Analytical Supervisor: Lead, cGMP Lab & Compliance

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

PCI Pharma Services is seeking a QC Analytical Supervisor to lead the quality control laboratory in supporting in-process, final product, and raw material testing. You will review and approve procedures, manage peer reviews, and ensure CGMP compliance across analytical methods.

The role involves client communication on OOS events and continuous process improvement. Responsibilities include supervising analysts, training staff, ensuring accurate documentation, and performing instrument

Qualifications

• 5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company.
• Experience working in a cGMP laboratory required.
• Experience working in a CMO (contract manufacturing/ development organization) preferred.
• Prior leadership experience is preferred.
• Bachelor of Science in a scientific area of study.
• Master of Science in a scientific area of study and 3+ years Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company.

Responsibilities

• Prioritize and distribute work to the analysts working in the QC Analytical laboratory.
• Conduct OOS and customer complaint investigations.
• Complete peer review of work executed within the analytical laboratory.
• Train new employees.
• Routine analytical testing of samples supporting incoming raw materials, in-process production and finished product testing.
• Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required.
• Perform instrument calibrations and preventative maintenance as needed.
• Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements.
• Write, review and revise SOPs as required.
• Other duties as assigned or required

Skills

Analytical Chemistry

cGMP experience

Leadership experience

Prioritization

Communication skills

Organization

Office software

Education

Bachelor of Science in a scientific field

Master of Science in a scientific field

Tools

HPLC

Karl Fischer

Particle Size Analyzer

UV-Vis

Densitometer

Osmometer

Job description

PCI Pharma Services is seeking a QC Analytical Supervisor to lead the quality control laboratory in supporting in-process, final product, and raw material testing. You will review and approve procedures, manage peer reviews, and ensure CGMP compliance across analytical methods.

The role involves client communication on OOS events and continuous process improvement. Responsibilities include supervising analysts, training staff, ensuring accurate documentation, and performing instrument