QA Associate( OSD Pharma Experience required)
Smart Media · Manassas, VA · 1 mo ago
On-siteQuality AssuranceFull-time
About the role
Responsible for batch record review and release, shipper label review and approval, expiry form creation and approval, lot memo review and approval, proof printing and approval, and new MBR and change control approvals.
Responsibilities
- Track batch record releases
- Release finished products, labels, and cartons in SAP
- Review and release incoming labels and cartons, including sampling, inspection, and approval
- Conduct Kenvue batch review and release, and upload documents in the SAP Portal
- Perform logging and reporting of weekly Kenvue batch releases
- Prepare annual product review for products
- Prepare and submit annual report data to GIL Team for FDA submission
- Create stability initiation forms
- Coordinate sample collection and shipping to customers
- Manage customer queries
- Share change controls with customers and follow up
- Log change controls
- Provide role-based new employee training
- Support audits by reviewing documents for accuracy and compliance
Requirements
- Experience in a GMP environment is preferred
- Strong communication skills
- Attention to detail
- Proficiency in Microsoft Excel