Quality Assurance Specialist, I

Vericel Corporation•Burlington, MA

7h•Onsite

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). This position is responsible for conducting day-to-day activities. This includes, but not limited to 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.

Requirements

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

Nice To Haves

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 (Examples: TrackWise and Veeva).

Responsibilities

Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
Responsible for the packaging and final batch disposition.
Responsible for inspection of 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.
Identifies deficiencies and works with cross functional departments to remedy them.
Identifies issues and provides recommendations for process improvements within the department.
Revise Standard Operating Procedures.
Other duties as assigned.