QA Specialist I – GMP Manufacturing & Cleanroom

Vericel® Corporation; Burlington (MA); On-site; USD 40,000 - 47,000; Full time

Job summary

Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility.

You'll gown into ISO 7 clean rooms and support release activities on a Tuesday–Saturday or Sunday–Thursday schedule, with some training/monthly relocation to Cambridge. Strong GMP knowledge and Excel skills are required.

Qualifications

• High School diploma or GED with 2 years of pharma/biotech experience or a Bachelor's degree with 0-1 years experience.
• Basic working knowledge of GMP regulations.

Responsibilities

• Review batch records and release intermediates within SOP timeframes.
• Packaging and final batch disposition responsibilities.
• Inspect final product in an ISO 7 cleanroom.
• Support day-to-day operations including archiving and label issuance.
• Follow procedures for review and release of intermediates and final product.

Skills

Quality Assurance

GMP knowledge

MS Word & Excel

Electronic Batch Records

Education

High School/GED + 2 yrs pharma

Bachelor's degree + 0-1 yrs pharma

Tools

TrackWise

Veeva

ERP systems

Job description

Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility.

You'll gown into ISO 7 clean rooms and support release activities on a Tuesday–Saturday or Sunday–Thursday schedule, with some training/monthly relocation to Cambridge. Strong GMP knowledge and Excel skills are required.