QC Analyst I​/II -Microbiology

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We are a leading regenerative medicine company in the advanced and acute wound care space 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.
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Perform routine quality control microbiology activities in support of product production and releases. The position interacts with other internal departments, including Apligraf Production, Pura Ply Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position may interact with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of routine activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting result.

Schedule for this role:
Monday‑Friday 11:00 am‑7:00 pm, some holiday work is required. Training schedule:
Monday‑Friday 8:30 am‑5:00 pm (first 3‑6 months)

• Perform and read environmental monitoring, critical utilities and personnel testing samples
• Perform and support microbiological testing, such as plate count enumeration, critical utilities monitoring, endotoxin testing, environmental monitoring, bioburden, and growth promotion
• Perform raw material, intermediate and non‑routine testing.
• Perform general laboratory maintenance activities
• Prepare and send out samples for microbiological identification and/or mycoplasma testing.
• Assist in revising SOPs
• Perform
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
• Participate in high‑level quality systems programs (Excursions, deviations CAPA, etc.)
• Participates, contributes and adds value in cross‑functional settings. Collaborates and communicates appropriately in all situations.
• Independently plans to execute projects and knows when to include others. Looks for ways to reduce errors and costs.
• Takes ownership for meeting all deliverables.

• AS or BS degree in a Microbiology or related field preferred. 1 or more years experience in a GMP or similarly regulated environment preferred.
• This position requires a minimum of 25 hours/week gowned in classified areas; ISO 5, ISO 7, ISO 8, and CNC.
• Handling biohazardous materials and chemicals;
  Basic laboratory safety procedures.
• Knowledge of cGMP and GLP regulations and compendial requirements, preferred.
• Proficiency with the computer software necessary to perform data handling tasks as well as accessing e‑mail and filling out reports (Microsoft Excel, Word, Outlook, Access).
• Good communication skills both written and verbal.
• Experience with testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, and Growth Promotion testing preferred.

• This position requires 3‑5 hours of standing per day with frequent stooping and lifting.
• Requires use of repetitive hand movement e.g. micropipetting and keyboard use for moderate or long periods of time.
• Occasional lifting/moving up to 15 pounds.
• 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.

• This position is primarily in a laboratory environment with approximately 20 % of the week in an office setting. The laboratory environment is a fast‑paced BL2 category lab that requires use of PPE such as gloves and lab coats. Activities are also performed in classified areas which require full gowning and special training. Standing…