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Granules Pharmaceuticals

QA Associate( OSD Pharma Experience required)

Granules Pharmaceuticals Manassas, Virginia, United States · $50K–$60K/yr

Pharmaceutical Manufacturing · 201-500 employees

7 h ago
qa Mid (2-5 yrs) Full-time United States
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About the role

The QA Associate is responsible for reviewing and releasing batch records, labels, and finished products within the SAP system. They also manage change controls, support audits, and prepare annual product review data for regulatory submissions.

What they look for

Batch Record Review SAP GMP Quality Assurance Documentation Compliance Change Control Microsoft Excel Product Release Sampling Inspection Data Reporting Stability Initiation Customer Query Management Employee Training Attention To Detail

Requirements

Candidates should have experience in a GMP environment and possess strong attention to detail. Proficiency in Microsoft Excel and effective communication skills are required for this role.

Full description

Description

  • 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

Requirements

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

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