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Jobs · Quality Assurance · Massachusetts

Quality Assurance Specialist, I

Vericel® Corporation · Burlington, MA · 1 wk ago
Quality Assurance$28.85–$34/hrFull-time

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).

About the role

This position is responsible for conducting day-to-day activities including batch record review, media disposition, label issuance, archiving, and final product packaging and release activities. The individual must be able to gown into classified manufacturing ISO 7 clean room areas to conduct inspection of final product.

Schedule

This position is onsite Tuesday - Saturday in our new Burlington, MA office but will require some days in our Cambridge office during the transition to our new facility.

Responsibilities

  • Perform and ensure review of batch records and release of intermediates within required timeframes outlined in SOPs.
  • Responsible for packaging and final batch disposition.
  • Inspect final product within an ISO 7 cleanroom.
  • Support day-to-day operations, including batch record review, label issuance, archiving, and verification with supervision oversight and in a timely manner.
  • Follow oral and written procedures for review and release of intermediate and final product.
  • Support projects as a QA resource.
  • Identify deficiencies and work with cross-functional departments to remedy them.
  • Identify issues and provide recommendations for process improvements within the department.
  • Revise Standard Operating Procedures.
  • Other duties as assigned.

Requirements

  • High School degree/GED with 2 years of relevant pharmaceutical/biotech experience or Bachelor’s plus 0-1 years of relevant pharmaceutical/biotech experience.
  • Basic working knowledge of GMP regulations.

Preferred Qualifications

  • Strong written and verbal communication skills.
  • Strong organization and time management skills.
  • Proficient in MS Word and Excel.
  • Experience with electronic batch records, ERP systems, and Quality Management Systems (e.g., TrackWise and Veeva).

Working Conditions and Physical Demands

  • Ability to lift and transport up to 30 lbs.
  • Must be able to work one weekend day.
  • Must be able to support rotating holiday coverage.
  • Must be able to gown into classified manufacturing ISO 7 clean room areas to conduct inspection of final product.
  • Must be able to gown into CNC areas.

Why Vericel?

  • Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
  • Career Growth: Be 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.

Pay

The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of posting is $28.85 to $34 per hour. The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity, and benefits may be provided in addition to the base compensation listed above.

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