The QC Analyst III/IV performs complex quality activities in support of product production and releases. The position has interaction with other internal departments, including Apligraf Production, FortaFlex Production, Puraply Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interaction with external entities including contractors and suppliers. The QC Analyst III/IV performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
• 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.
• Generate complex trend reports as they relate to quality testing.
• 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.).
• 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.
• Looks for ways to reduce errors and costs.
• Takes ownership for meeting all deliverables.
This position requires a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K. This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires use of repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time.
Preferred Education and Experience:
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.