QC Analyst II, Microbiology
Job Req code: 763
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 located 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 II 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.
- 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 in-process 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.
- This position requires a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K. This position requires 3-5 hours of standing per day with frequent stooping and lifting. This position also requires use of repetitive hand movement e.g. micropipetting and keyboard use for moderate or long periods of time.
- Performs data review and management
Bachelor’s Degree in Microbiology or related field required.
2-4 years' Microbiology experience in a GMP/GLP regulated environment required.
Pre-Employment Testing: 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.
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