Job Description Job Description Summary
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. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.
Job Responsibilities
Perform a broad variety of basic and moderately complex tests with documentation according to GMP
Review data and assess against established acceptance criteria
Perform technical review of peer-generated data
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
Perform equipment qualification / maintenance
Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures
Support the maintenance and compliance of operational areas
Assure and apply GMP throughout operations
Coordinate with customers to support multi-site operational activities
Support internal and external audits and regulatory inspections
Works to meet schedules, timelines, deadlines
Participate in and/or lead group and project teamwork; project and process improvements
Write protocols and reports under limited supervision
Meets scheduled performance of 95% on time
Perform other duties as requested by managers to support Quality activities
Job Requirements
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.
Routinely exercises sound judgment, reasoning and problem solving.
Capable of working under limited supervision and determining own short term priorities. Enable Skills-Based Hiring No CH - FTE Replacement (External Contractor) Reason
Additional Details
- CH - FTE Replacement (External Contractor) Reason : N/A
- Will Contingent Worker allocate time to project task codes? : No
- If yes, please enter exact project codes for allocation. : N/A
- Will this position require driving? : No
