QC Analyst I/II Materials

Role Summary

QC Analyst I/II (Materials) conducts quality activities in support of material inspection, testing coordination, data collation and review, and material disposition for Clinical and Commercial Operations and Quality Control testing. The role interfaces with Operations, Quality Assurance, Materials, Regulatory Affairs and Logistics, as well as external contractors, test labs and suppliers. It ensures regulatory compliance by inspecting, coordinating testing, trending, and reporting results. Periodic weekend, holiday and evening on-call coverage may be required.

Responsibilities

• Perform material inspections.
• Perform tissue inspections.
• Submit test requests to the QC functional areas to coordinate testing.
• Coordinate shipping of materials to external test labs.
• Perform sampling of various chemicals.
• Collate results and document results to submit to Quality Assurance for final dispositioning.
• Generate trend reports as they relate to Quality Control testing.
• Revise SOPs.
• Maintain Equipment and inspection tools.
• Support material qualifications.
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.

Qualifications

• Bachelor’s Degree in Science or equivalent
• 1-4 years of related experience in a cGMP regulated environment
• Materials and/or final product inspection experience required
• Pharmacopeia experience required

Additional Requirements

• Able to lift 50 lbs. and 50% of time standing in workday
• Visual acuity screening test and periodic re-testing required for QC hires