QC Analyst III/IV - Cell Culture

Norwood, MA

Job Req code: 723

Category: Quality Systems

We have unique opportunities 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. Empowering Healing.


Organogenesis corporate headquarters is in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds).  Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products. 


The QC Analyst III/IV performs advanced quality activities in support of product production and releases. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position also interacts with external entities including contractors and suppliers. The QC Analyst III/IV performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.


This position also requires use of repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time. Occasional Class 10K gowning is required to support QC activities.


Requires a minimum of bachelor’s degree in Biology or related field, with 5-7 years of related experience.  Cell Culture experience required. Experience in Biologics, GMP regulated environment preferred.  Flow Cytometry experience preferred.
 

Requirements

  • Primary responsibility for the day-to-day activities in the Cell Culture laboratory in support of product release testing
  • Scientific/technical contributor on cross-functional projects related to all Cell Culture activities and Bioassay development
  • Interact and coordinate with Manufacturing on a daily basis.
  • Work closely with the QC bio-assay lab in support of ELISA testing
  • Coordination of test sample receipt and scheduling.
  • Perform visual inspection of finished product.
  • Donated tissue receipt and transfer
  • Identify and report areas for process improvement
  • Generate and execute feasibility/validation protocols
  • Generate trend reports as they relate to quality testing.
  • Generate deviation reports, out-of-specification reports, CAPAs, Change Controls and non-routine investigations.
  • Revise/Create SOPs.

Requires a minimum of bachelor’s degree in Biology or related field, with 5-7 years of related experience.  Cell Culture experience required. Experience in Biologics, GMP regulated environment preferred.  Flow Cytometry experience preferred.

TEST REQUIREMENTS
Quality Control new hires are required to undergo a visual acuity screening test and periodic re-testing during employment. The results of this testing are neither a condition for employment nor of continued employment and are utilized solely for purposes of qualifying individuals for performance of certain visual tests/assays requiring minimum visual standards.