QC Analyst IV/Team Lead-Materials

150 Dan Road, Canton, Massachusetts, 02021, United States

Job Req code 255

Category: Quality

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions.  Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The QC Analyst IV, Materials, performs quality control activities in support of raw material, intermediate products and starting material release activities.   The QC Analyst IV interacts with other internal departments, including Operations, Human Tissue Manufacturing, Cell Culture, Cell Bank Production, Quality Assurance, Materials, and Logistics in support of providing uninterrupted supply of materials to meet the production and testing demands.  The position is responsible for coordination of material inspections, sampling, internal/external sample management and data review in support of material release activities.  The position also has interactions with external entities including contractors, test labs and suppliers. The QC Analyst IV performs a wide variety of activities to ensure compliance with applicable regulatory requirements by inspecting, coordinating testing, trending, and reporting results.   Periodic weekend, holiday and evening on-call coverage may be required.


How you will Achieve It:

  • Support Computer System validations and maintenance related to Material release process.
  • Collate and document results to submit to Quality Assurance for final dispositioning.
  • Generate trend reports as they relate to QC testing and material release metrics.
  • Author and Revise SOPs.
  • Maintain Equipment and inspection tools.
  • Review and support material qualifications according to company guidelines.
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
  • Coordinate shipping of materials to external test labs.
  • Perform material inspections.
  • Perform tissue inspections.
  • Submit test requests to the QC functional areas to coordinate testing.


What You Need to Achieve It:

  • Bachelor’s Degree in Science or equivalent
  • 5-7 years of related experience in a GMP regulated environment
  • Materials and/or final product inspection experience required
  • Experience with implementation of GMP compliant electronic systems, i.e. Microsoft Dynamics 365 (D365) is strongly desired. 
  • Background in GMP compliant software solutions in support of sample management, documentation control and print inspections is preferred
  • Pharmacopeia experience required
  • Change Control experience required


Physical Requirements:

  • Pass Annual Vision Screening Test
  • Able to lift 50 lbs. 


Environmental Conditions

  • Requirements include following gowning procedures, usually lab coats, gloves and sleeves.  
  • The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.


What can we offer you?

  • 401k -- generous employer match with immediate vesting and financial planning resources
  • Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
  • Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
  • Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
  • Paid maternity leave and parental leave for all new parents
  • Adoption benefits
  • Education Assistance Policy - $5,000 per year for all employees
  • Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
  • Employee Assistance Program
  • Generous paid time off including vacation, floating holidays, sick days, and company holidays
  • Free parking including an electric charging station (Canton and La Jolla)
  • Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint


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, genetic information or any other characteristic protected by law.