QA Release Specialist — GMP, SAP & FDA Documentation

Granules Pharmaceuticals; Manassas (VA); On-site; USD 60,000 - 90,000; Full time

Job summary

Granules Pharmaceuticals in Manassas, VA seeks a detail-oriented professional to perform batch record review and release activities. The role includes reviewing labels, expiry forms, MBRs, and change controls, with duties in SAP for finished products and cartons.

The candidate should have GMP experience or exposure, strong communication, and Excel skills to ensure accurate documentation, releases, and audits supporting FDA submissions.

Qualifications

• Experience in GMP environment is preferred.
• Strong communication and attention to detail.
• Proficient in 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 MBRs 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

Skills

Attention to detail

Communication skills

Microsoft Excel

Tools

SAP

Job description

Granules Pharmaceuticals in Manassas, VA seeks a detail-oriented professional to perform batch record review and release activities. The role includes reviewing labels, expiry forms, MBRs, and change controls, with duties in SAP for finished products and cartons.

The candidate should have GMP experience or exposure, strong communication, and Excel skills to ensure accurate documentation, releases, and audits supporting FDA submissions.