Quality Inspector, Senior

Vericel CorporationBurlington, MA
21d$30 - $34Onsite

About The Position

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).  Position Summary:  The individual will be responsible for raw material sampling and inspection internally and at a third-party warehouse. Also responsible for overseeing the inventory of laboratory chemicals and critical reagent supplies across both the Cambridge and Burlington facilities.   Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work Monday-Friday onsite. Position Scope:  Perform inspection, sampling, and release/rejection of components and raw materials as per SOP's and specifications. Individual will monitor various stages of processing along with the appropriate paperwork in compliance with specifications.  Collaborate regularly with Supply Chain, QA and Materials Management Partner with outside vendors when required perform inspection and of components and raw materials as well as submitting samples for testing.  Support of Quality Control operations by performing basic laboratory responsibilities including environmental monitoring, lab support, inventory of laboratory chemicals and critical reagent supplies, and sample submissions to contract labs. Manage laboratory ordering and inventory management. Update and revise transactions in inventory management system. Flexible and responsive to customer needs.

Requirements

  • HS Diploma, 4+ years’ industry experience in cGMP, or equivalent.
  • BS Degree, 0-2 years’ industry experience in cGMP, or equivalent
  • Direct work experience in a cGMP and pharmaceutical/medical device raw materials quality inspection system.
  • Direct technical experience writing CAPA’s
  • This position will be based in Cambridge MA but will require travel between Cambridge, Burlington MA, and warehouse locations regularly (~50%)
  • Must be able to lift/pull up to 40 pounds.
  • Personal transportation required.
  • Occasional Weekend or Holiday coverage (as needed).
  • Rotating off-shift alarm coverage. May be required to carry a company issued cell phone

Nice To Haves

  • Effective time management, multitasking and organizational skills.
  • Strong attention to detail and cross functional team experience.
  • Computer skills in systems such as Microsoft Word, Excel and TrackWise.
  • Knowledge of Laboratory Information Management Systems (LIMS).

Responsibilities

  • Perform inspection, sampling, and release/rejection of components and raw materials as per SOP's and specifications.
  • Monitor various stages of processing along with the appropriate paperwork in compliance with specifications.
  • Collaborate regularly with Supply Chain, QA and Materials Management
  • Partner with outside vendors when required perform inspection and of components and raw materials as well as submitting samples for testing.
  • Support of Quality Control operations by performing basic laboratory responsibilities including environmental monitoring, lab support, inventory of laboratory chemicals and critical reagent supplies, and sample submissions to contract labs.
  • Manage laboratory ordering and inventory management.
  • Update and revise transactions in inventory management system.
  • Flexible and responsive to customer needs.

Benefits

  • Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
  • Career Growth: Be a part of a growing organization with opportunities to expand your impact.
  • Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.
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