Quality Assurance Specialist

4 days ago

Columbia, South Carolina, United States GForce Life Sciences Full time
Job Title: Quality Assurance Associate

At GForce Life Sciences, we are seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities:
  • GMP Compliance: Ensure that all outsourced clinical manufacturing, packaging, labeling, and testing activities meet Good Manufacturing Practice (GMP) requirements.
  • QA Review: Perform quality assurance reviews of API and Drug Product manufacturing records for research & development products to ensure accuracy and compliance with GMP requirements.
  • Clinical Packaging: Perform quality assurance reviews of Clinical Packaging records for research & development products to ensure accuracy and compliance with GMP requirements.
  • Test Results: Review analytical test results/raw data to ensure results meet specifications and are appropriately documented.
  • Quality Events: Review quality events, deviations, investigations, and change controls.
  • Project Management: Escalate project/supplier issues/trends to GPQ Management when appropriate to ensure timely resolution.
  • Collaboration: Work collaboratively with Vendors as well as the GPQ Department and other functional areas across Affiliates and Subsidiaries to ensure compliance with local and global requirements and regulatory requirements.
  • System Utilization: Utilize the TrackWise Digital eQDMS System to enter batch-related information and complete associated batch disposition workflow.
  • Record Maintenance: Maintain GMP records (document storage, archiving, retrieval)
  • Reporting: Support GPQ IMP R&D Metrics/Dashboards/Management Reviews by compiling batch record review/release data and/or other ad hoc reporting requests.
  • Inspection Readiness: Support inspection readiness activities.
  • Process Improvement: Support Trackwise Digital Quality R&D Division process improvement projects (UAM/UAT testing).
Requirements and Preferences:
  • Education: Bachelor's degree in Engineering, Chemistry, Biology, or related Science
  • Experience: 2-5 years of related experience in pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material
  • Software Skills: Experience using MS Office (Word, Excel, PowerPoint)
  • eQDMS Experience: Experience using TrackWise Digital or similar eQDMS workflow interface.
  • GMP Knowledge: Thorough understanding of GMP requirements and the Drug Development process.
Preferred Qualifications:
  • Quality Oversight: Experience in quality oversight of R&D/Clinical product manufacturing and packaging
  • TrackWise Digital Experience: Experience in TrackWise Digital
Benefits:
  • Contract Length: 12+ month contract, potential to extend
  • Remote Work: Fully remote, EST
  • Benefits Package: Benefits (medical, dental, vision, 401k)
  • Paid Holidays: Paid holidays
  • Pay Range: Pay Range hr

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