QA Associate( OSD Pharma Experience required)

Granules PharmaceuticalsManassas, VA
$50,000 - $60,000

About The Position

The QA Associate will be responsible for a variety of tasks related to batch record review and release, label and carton management, product reviews, and customer support. This role requires attention to detail and experience in a GMP environment.

Requirements

  • Experience in GMP environment is preferred
  • Communication skills and attention to detail.
  • Microsoft Excel

Responsibilities

  • Batch Record Review and Release
  • Shipper Labels Review and Approval
  • Expiry Form Creation and Approval
  • Lot Memo Review and Approval
  • Print Proofs Review and Approval
  • New MBR’s and Change Control Approvals
  • Keep track of Batch Record releases
  • Release Finished products, Labels, and Cartons in SAP
  • Incoming Labels and Cartons Sampling, Inspection and Release
  • Kenvue Batch Review and Release and upload the documents in SAP Portal
  • Logging and Reporting Weekly Kenvue Batch Releases
  • Preparing Annual Product Review for the products
  • Prepare and submit Annual Report Data to GIL Team for FDA Submission
  • Stability Initiation Forms Creation
  • Sample Collection and Shipping to Customers
  • Customer Query Management
  • Sharing Change Controls with the Customers and follow-up
  • Logging Change Control
  • Providing role-based new Employee Training
  • Supporting audits by reviewing documents for accuracy and compliance
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