Supervisory Quality Assurance Specialist

The duties of this position include, but are not limited to:

• Overseeing the daily operation of the Clinical Materials Manufacturing Section (CMMS), Division of Technical Operations (DTO) ensuring that VA, CSP, PCC, FDA, DEA, and other regulatory partner regulations, policies and procedures are being followed, adequate resources and tools are available for CMMS staff
• Assists other Division of Technical Operations (DTO) and Division of Quality Assurance (DQA) Section Chiefs in the development of metrics necessary to determine the numbers and types of positions necessary to meet the current and future demands and complexities of DTO and MCTs
• Recommending and designing new quality programs to meet national needs with respect to the conduct of clinical trials manufacturing, packaging, labeling, and distribution
• Analyzing section financial situations and needs, determines and evaluates risk, and employs knowledge management tools and techniques to solve problems in executing studies, including identifying core competencies that create a quality culture and system
• Responsible for the staff training program in current cGMP, Corrective Action/Preventative Action (CAPA), Root Cause Analysis (RCA) and is responsible for coordinating inhouse or contract training for PCC staff in cGMP
• Interpreting FDA regulations under 21 CFR 210 and 211, Food and Drugs for applicability to specific drugs and medical devices and Federal guidelines governing the collection and use of biosamples associated with clinical trials supported by the PCC
• Plans, develops, and conducts methodologies to qualify suppliers of critical clinical trial materials (CTM)
• Conducting investigations and analyses of suspected adverse quality or conditions and when quality problems are detected, involving pharmaceuticals, devices, clinical supplies or biosamples, initiates and documents corrective action (CA) on the contractor producing those products or the collection, processing, storage and inventory of biospecimens

Work Schedule: Monday - Friday, 7:30 - 4:00

Telework: This position may be authorized for telework. Telework eligibility will be discussed during the interview process.

Virtual: This is not a virtual position.

Position Description/PD#: PD931870

Relocation/Recruitment Incentives: Not Authorized

Critical Skills Incentive (CSI): Not Approved

Permanent Change of Station (PCS): Not Authorized