Quality Control Specialist

4 weeks ago


Norwood, Massachusetts, United States Organogenesis Full time
About Us

We are a leading provider of advanced wound care products and regenerative medicine solutions. Our mission is to empower patients with life-changing treatments and support the healing of musculoskeletal injuries and degenerative conditions.

Job Summary

We are seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for performing quality activities in support of product production and release. This includes conducting testing, trending, and reporting results to ensure compliance with applicable regulatory requirements.

Key Responsibilities
  • Perform daily lab housekeeping and maintenance, including temperature charting, restocking, cleaning, and sample receipt, logging, and disposition.
  • Conduct routine and non-routine testing of ASA in support of Stability, Process Validation, and Method Validation.
  • Report and review final product results, participate in data analysis and review, and interact with Quality Assurance, R&D, and Manufacturing.
  • Work closely with the QC Cell Culture lab in support of cell-based potency assays, perform visual inspection of vialed product, and participate in receipt, inspection, and transfer of tissue donations for both the ASA and Affinity Product lines.
  • Collaborate on deviation reports, out-of-specification reports, CAPAs, Change Controls, and non-routine investigations, and revise/review SOPs.
Requirements
  • Requires a minimum of bachelor's degree in biology or related field, with 1-3 years of related experience.
  • Lab experience required, experience in Biologics/chemistry, GMP regulated environment preferred.
What We Offer
  • Competitive Pay
  • 401K - generous employer match with immediate vesting and financial planning resources
  • Education Assistance Policy - $5,000 per year for all employees
  • Medical, Dental, and Vision
  • Flexible Spending Account or Health Savings Account
  • Wellness Program
  • Three weeks of vacation, 4 floating holidays, sick days, and company holidays
  • Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
Equal Opportunity Employer

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, or any other characteristic protected by law.



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