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QA Associate( OSD Pharma Experience required)

Granules Pharmaceuticals
Posted a day ago, valid for a month
Location

Manassas, VA, US

Salary

$50,000 - $60,000 per year

Contract type

Full Time

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Sonic Summary

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  • The job involves responsibilities such as batch record review and release, approval of shipper labels, and creation of expiry forms.
  • Candidates should have experience in a GMP environment and possess strong communication skills and attention to detail.
  • The position requires proficiency in Microsoft Excel and involves logging and reporting weekly batch releases.
  • A minimum of 3 years of relevant experience is required, and the salary for this role is $70,000 per year.
  • Additional tasks include managing customer queries, training new employees, and supporting audits for compliance.

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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