QA Associate: Batch Release & Compliance Champion

Granules Pharmaceuticals Inc.; Manassas, Northern (VA, KY); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Granules Pharmaceuticals Inc. is seeking a Quality Assurance/Documentation professional in Virginia to review and release batch records, approve shipper labels, and manage related GMP documentation. The role involves creating forms, reviewing change controls, and ensuring accurate documentation for FDA submissions.

Responsibilities include coordinating with QA, handling product releases in SAP, and supporting audits with precise record-keeping and timely reporting to internal teams.

Qualifications

• Experience in GMP environment is preferred.
• Strong communication skills and attention to detail.
• Proficiency in Microsoft Excel.

Responsibilities

• Review and release batch records.
• Review and approve shipper labels.
• Create and approve expiry forms.
• Review and approve lot memos.
• Review print proofs.
• Manage new MBRs and change controls.
• Track batch record releases.
• Release finished products, labels, and cartons in SAP.
• Inspect and release incoming labels and cartons; sample as required.
• Log Kenvue batch review and releases in SAP portal.
• Prepare annual product reviews for the products.
• Prepare and submit annual report data to the GIL Team for FDA submission.
• Create stability initiation forms.

Skills

Communication skills

Attention to detail

Tools

Microsoft Excel

Job description

Granules Pharmaceuticals Inc. is seeking a Quality Assurance/Documentation professional in Virginia to review and release batch records, approve shipper labels, and manage related GMP documentation. The role involves creating forms, reviewing change controls, and ensuring accurate documentation for FDA submissions.

Responsibilities include coordinating with QA, handling product releases in SAP, and supporting audits with precise record-keeping and timely reporting to internal teams.