QC Analyst II/ III-Cell Culture

333 Providence Highway, Norwood, Massachusetts, 02062, United States

Job Req code 379

Category: Quality

About Us

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 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 surgical & sports medicine products support the healing of musculoskeletal injuries and degenerative conditions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

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

 

How You Will Achieve It:

  • Perform cell banking and cell bank release testing.
  • Perform cell counting for release assays.
  • Perform visual inspection of finished product.
  • Maintain lab equipment through preventative maintenance and cleanings.
  • Generate trend reports as they relate to quality testing.
  • Create/revise SOPs.
  • Technical contributor on cross-functional projects related to all Cell Culture activities and Bioassay development.
  • Work closely with the QC Chemistry Lab in support of ELISA testing and other Chemistry based assays.
  • Coordination of test sample receipt and scheduling.
  • Donated tissue receipt and transfer.
  • Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.

Requirements

What You Need to Achieve It:

Requires a minimum of Bachelor’s Degree in Biology or related field, with 2-7 years of related experience.  Cell Culture experience required. Experience in Biologics/chemistry, GMP regulated environment preferred

Physical 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.

 

What sets us apart?

  • Competitive Pay
  • 401K – vested immediately with 100% match
  • 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

 

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.