Conducting day-to-day activities including batch record review, media disposition, label issuance, archiving and final product packaging and release activities.
Perform batch records review and release of intermediates.
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.
Follow oral and written procedures for review and release of intermediate and final product.
Support projects as a QA resource and identifies deficiencies.

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
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).

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.

Quality Assurance Specialist, I

Key skills