Scope of Position:
The QA Specialist position coordinates system-wide compliance of VIRxSYS to federal regulations promulgated by the FDA under 21 CFR Part 210 and 211 [current Good Manufacturing Practice regulations (cGMP)]. Additionally, the QA Specialist is responsible for development and implementation of QA systems and procedures. Where applicable, the QA Specialist supports clinical trial activities at clinical sites and handles logistics between clinical sites and VIRxSYS.
Major Responsibilities:
- Keep Department Head informed of any problems that are likely to affect the integrity of an operation, i.e. have an impact on GMP compliance.
- Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs).
- Assist with development of documentation (batch records, documentation supporting regulatory submission(s), etc.)
- Perform internal audits and assist with vendor/supplier audits. Generate audit report(s). Ensure noted deficiencies are addressed. For internal QA audits, determine where improvement in operation can be made. With Department Head approval, implement corrective action.
- Collaborate with functional groups to evaluate and address complex issues such as change controls, deviations, corrective and preventive action (CAPA) and failure investigations
- Review clinical trial test procedures/data (subject monitoring tests) to ensure compliance and accuracy. Report results to clinical sites.
- Develop, validate and qualify QC spreadsheets to ensure 21 CFR Part 11 compliance.
- Evaluate and approve Production and QC documentation for product batch release when needed. Recommend lot disposition.
- With Department Head guidance, implement raw material certification program.
- Review, approve and release raw materials associated GMP manufacturing.
- Develop cGMP and QA training materials. Provide employee training.
- Review and verify the accuracy for printed materials.
- Review validation protocols and reports to comply with FDA expectations for validation
- Participate in projects in support of Quality Department goals, such as document audits, inspection support, etc.
- Perform other duties as required
Skills:
Detail oriented, problem solver, able to review data and draw analytical conclusions, good writing and oral skills, tactful, organized, able to work under pressure, able to multi-task and juggle multiple priorities, able to switch gears on pressing concerns. Good interpersonal skills and ability to work in a team environment.
Educational Requirements:
- Bachelor’s Degree in any biological science with at least 5 years. Strong cGMP compliance background and experience.
- Computer knowledge preferably in design and troubleshooting of computer systems and application software.
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