QC Analyst III/IV -Materials

Canton, MA

Job Req code: 1000

Category: Quality Systems

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives.

The QC Analyst III/IV performs quality activities in support of material inspection, material testing coordination, data collation, data review, material disposition and final product inspection. The position interacts with other internal departments. The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst III/IV performs a wide variety of activities to ensure compliance with applicable regulatory requirements in support of inspecting, coordinating testing, trending, and reporting results.   The QC Analyst III/IV will lead internal QC Material specific assessments including but not limited to, non-conforming raw materials, internal/external deviations, OOTr/OOS results etc.  The QC Analyst III/IV will support continuous improvement initiatives and participate in Quality System requirements for new and existing materials, e.g. risk management, CAPA and change controls. Periodic weekend, holiday and evening on-call coverage may be required.

Key Responsibilities:

  • Author and Revise SOPs.
  • Lead material related Quality System activities: Deviations; Non-conforming material reports; Internal Audit responses, risk assessments, change controls etc.
  • Support material qualifications in compliance with company policies and applicable regulatory guidelines.
  • Support continuous improvement projects
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
  • Perform material inspections.
  • Perform tissue inspections.
  • Perform Final Product Inspections.
  • Submit test requests to the QC functional areas to coordinate testing.
  • Coordinate shipping of materials to external test labs.
  • Collate results and document results to submit to Quality Assurance for final dispositioning.
  • Generate trend reports as they relate to Quality Control testing

Requirements

  • Preferred Education and Experience:

  • Bachelor’s Degree in Science or equivalent
  • 4-6 years of related experience in a GMP regulated QC environment
  • Materials and/or final product inspection experience required
  • Pharmacopeia experience required
  • Change Control experience required
  • Pass Annual Vision Screening Test
  • Able to lift 50 lbs. and 25-50% of time standing in workday.
  • Pass Annual Vision Screening Test
  • Able to lift 50 lbs. and 25-50% of time standing in workday.