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Quality Assurance Specialist
1 month ago
***THIS IS NOT A VIRTUAL POSITION, YOU MUST LIVE WITHIN OR BE WILLING TO RELOCATE WITHIN A COMMUTABLE DISTANCE OF THE DUTY LOCATION***
This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds.
Duties will include but may not be limited to the following:
Plans, develops, implements, and administers a wide variety of quality assurance management systems and procedures to support clinical trials for the inspection, storage, handling, manufacturing and packaging of pharmaceuticals and medical devices supporting complex national clinical trials and research programs.
Develops, implements, and assures effective quality control procedures customized to every study, by identifying, proofing, measuring, and analyzing customer requirements in relation to established procedures to determine adequacy, reliability, and validation of processes, to promote process and product quality, and ensure continuous process improvement.
Develops, implements, and maintains Master Production Records as to the overall specifications for the quality of every drug and medical device used for each clinical trial. Develops sampling plans and calculates required assay and retained sample needs to support stability and release protocols.
Approves label designs to ensure conformance to cGMP regulations.
Leads Process Action Teams (PATs); coordinates and promotes technical quality control (QC) functions and performs quality assurance (QA) operations throughout the facility to ensure that adequate quality provisions are planned, developed, and implemented.
Interfaces with suppliers, production staff and customers to select, analyze, and audit various processes and identify methodologies for process improvement to enhance customer satisfaction and ensure successful completion of clinical trials.
Serves as a technical expert in FDA regulatory requirements for drugs and medical devices.
Works with study team members to establish drug assay specifications, quality metrics and product acceptance standards for cGMP compliance.
Communicates with key officials, managers, contractors, and other individuals within and outside the agency concerning quality matters or investigations, and to seek guidance for establishing acceptance standards or critical quality parameters of drugs or devices.
Provides informal and formal guidance and instruction to production personnel and contractors, regarding deficiency corrections, inadequate production performance, and other nonconforming product improvement and disposal.
Mentors and assists in the training of other QC personnel, and in providing quality control, procedural and cGMP training to all staff.
Performs other duties as assigned.
Work Schedule:
Monday - Friday 8:00 am - 4:30 pm
Recruitment & Relocation Incentives:
Not authorized
Critical Skills Incentive (CSI)
: Not approved
Telework:
VA supports the use of telework as a way to help attract and retain talented individuals in public service, increase worker productivity, and better prepare the agency to operate during emergencies. This position may be authorized for telework. Telework eligibility will be discussed during the interview process.
