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QA Specialist I at Global Pharmatek

QA Specialist I

Global Pharmatek Tampa, FL Full-Time
Title: QA Specialist I
Location: Tampa, FL
Duration: 12 months
Shift: 1st Shift, 8 hours, Monday - Friday,
flexible to overtime as may be required

Description:
Key responsibilities:
  • 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.
Key requirements:
  • 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

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