Quality Control Analyst

With limited supervision, QC Associate II, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities

• Perform a broad variety of basic and moderately complex tests with documentation according to GMP
• Evaluate data to identify trends and/or establish limits
• Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Identify and troubleshoot technical problems
• Identify gaps in systems and procedures
• Receive and provide training
• Participate in assay transfer and assay validation

• B.S. /B.A. degree and three years experience or Master’s Degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.
• Strong verbal and written communication skills, ability to organize and present information both formally and informally.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

• Associate

• Contract

• Research and Manufacturing

• Pharmaceutical Manufacturing and Biotechnology Research