The QC Analyst, I/II, III and III/IV will perform complex quality activities in support of product production and releases. This person will work with other internal departments including, Quality Assurance, Validation, Calibration, Materials, and Logistics as well as external entities including contractors and suppliers.
The QC Analyst will perform a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
- Perform and/or oversee raw material, intermediate and non-routine testing.
- Perform and/or oversee endotoxin, microbiologic, and water testing.
- Perform and/or oversee reading 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.
- Generate complex trend reports as they relate to quality testing and revise SOPS
- Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
- Participate extensively in high-level quality systems programs (CAPA, etc.) and provide input into failure investigations
- 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, look for ways to reduce errors and costs.
Minimum of a Bachelor’s Degree or equivalent and Microbiology experience in a GMP/Medical Device/ Pharmaceutical or Biological regulated environment. Degree in Microbiology or related field required.
Experience in Aseptic Processing is preferred.
Experience/comfortable working in Class 100, 10k, 100k clean rooms and be gowned for a minimum of 20-25 hours a week.