Title: QA Specialist I
Location: Tampa, FL
Duration: 12 months
Shift: 1st Shift, 8 hours, Monday - Friday,
flexible to overtime as may be required
- Verification of the companys compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements in manufacturing and operational support areas.
- Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
- Perform external audits of suppliers/vendors/off-site facilities.
- Act as a customer interface during on-site audits, conference calls and other standard means of communication. Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
- Prioritize and manage a variety of projects simultaneously.
- May need to lead and direct the work of others.
- Review and approve validation documents.
- Review and Master Batch Records (MBR) and supporting documents.
- Perform review/release of batch records, as needed.
- Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
- GMP compliance and Part 11 compliance knowledge preferred.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
- 1-3 Years Experience
- Test Automation
- Software Testing
- Performance Testing
- Test Data
- Manual Testing
- Hp Quicktest Professional