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.
· Ensure overall VIRxSYS compliance to cGMP’s and support compliance to GLP and GCP’s
· Develop and (with Dept. Head approval) implement quality systems and procedures.
· Establish, Implement and administer quality tracking software system (Trackwise). Liaison with software contractors and hardware vendors for system maintenance.
· In collaboration with the Dept. Head, develop and write key Quality documents such as the Quality Manual and Master Validation Plan.
· Audit Quality Systems internally and externally for compliance to cGMP.
· Assess validation requirements for equipment, facilities, computer, processes and test assays. Review validation protocols and reports to comply with FDA expectations for validation.
· Review clinical trial test data (patient monitoring tests) to ensure accuracy.
· Develop, validate and qualify QC test spreadsheets to ensure 21 CFR Part 11 compliance.
· Perform some straightforward internal equipment validation. Review external equipment validation protocol and reports.
· Evaluate and approve Production and QC documentation for clinical data and product batch release when needed.
· With Department Head guidance, implement raw material certification program.
· Establish and formalize Standard Operating Procedures related to QA systems, barcode and clinical trial material, where appropriate, procedures related to validation.
· Interact on departments' behalf to assist and direct the completion of failure investigations.
· Develop cGMP and QA training materials. Provide employee training.
· Review and verify the accuracy for all printed materials.
· Develop and maintain spreadsheets and databases to maintain cGMP compliance.
Participate in projects in support of Quality Department goals, such as document audits, inspection support and other projects as required
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.
· Bachelor’s Degree in any biological science with at least 3-5 years experience. Strong cGMP compliance background and experience.
· Computer knowledge preferably in design and troubleshooting of computer systems and application software. Knowledge of Software development to serve as a liaison between VIRxSYS and software vendors.
If you qualify, let us know by e-mailing your CV and references to: E-mail: employment@virxsys.com.
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