Description:
• Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.
• Performs QA review of API and Drug Product manufacturing records for research & development products to ensure accuracy and compliance with GMP requirements.
• Performs QA review of Clinical Packaging records for esearch & development products to ensure accuracy and compliance with GMP requirements.
• Reviews analytical test results/raw data to ensure results meet specifications and are appropriately documented.
• Reviews quality events, deviations, investigations, and change controls.
• Escalates project/supplier issues/trends to GPQ Management when appropriate to ensure timely resolution.
• Works 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.
• Utilizes the TrackWise Digital eQDMS System to enter batch-related information and complete associated batch disposition workflow.
• Maintains GMP records (document storage, archiving, retrieval)
• Supports GPQ IMP R&D Metrics/Dashboards/Management Reviews by compiling batch record review/release data and/or other ad hoc reporting requests.
• Supports inspection readiness activities.
• Supports Trackwise Digital Quality R&D Division process improvement projects (UAM/UAT testing).
Requirements and Preferences:
• Bachelor’s degree in Engineering, Chemistry, Biology, or related Science
• 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
• Ability to work independently.
• Ability to handle interactions and resolve issues with internal customers and GMP Vendors in a tactful, professional, and effective manner.
• Ability to manage and prioritize multiple tasks.
• Experience using MS Office (Word, Excel, PowerPoint)
• Experience using TrackWise Digital or similar eQDMS workflow interface.
• Excellent interpersonal and communication skills
• Thorough understanding of GMP requirements and the Drug Development process.
• Analytical problem solving and decision-making skills.
• Ability to identify gaps/risks and propose corrective and preventative actions.
Preferred:
• Experience in quality oversight of R&D/Clinical product manufacturing and packaging
• Experience in TrackWise Digital
Details:
- 12+ month contract, potential to extend
- Benefits (medical, dental, vision, 401k)
- Paid holidays
