Quality Control Analyst, Microbiology
Job Req code: 846
Category: Quality Systems
Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. 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.
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.
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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