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

How You Will Achieve It:

• Proficient cGMP documentation
• Performs sample receipt and staging.
• Performs environmental monitoring of classified areas.
• Performs USP bioburden and sterility testing.
• Perform raw material, intermediate and non-routine testing.
• Perform endotoxin, microbiologic, and water testing.
• Perform and read environmental, personnel, and sterility testing.
• Prepare and send out samples for microbiological identification and/or mycoplasma testing.
• Perform visual inspection of final product.
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
• Provide input into failure investigations.
• Participates, contributes, and adds value in cross- functional settings. 

Requirements

What You Need to Achieve It:

• Requires a Bachelor’s Degree in Microbiology or related field, with a minimum of 2-4 years of Microbiology experience in a GMP/Medical Device/ Pharmaceutical or Biological regulated environment. 

Physical Requirements:

This position requires:

• A minimum of 25 hours/week gowned in classified areas; ISO 5, 7, and 8.
• 3-5 hours of standing per day with frequent stooping and lifting.
• Use of repetitive hand movement e.g. micropipetting and keyboard use for moderate or long periods of time.
• Precise manual dexterity for fine-detail tasks, including the use of needles and scalpels for QC microbiology procedures.

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