Quality Release Specialist - SAP & GMP Compliance

Granules Pharmaceuticals, Inc.; Manassas (VA); On-site; USD 50,000 - 60,000; Full time

Job summary

Granules Pharmaceuticals, Inc. is seeking a QA Documentation Specialist to support batch release and record review in SAP. The role covers labeling, carton release, sampling, inspection, and documentation uploads to SAP Portal, with weekly batch release reporting and change-control coordination.

Candidate will prepare annual product reviews, submit data for FDA submissions, and assist with employee training. Experience in GMP environments and strong Excel skills are preferred.

Qualifications

• Experience in GMP environment is preferred.
• Excellent written and verbal communication skills.
• Attention to detail in documentation and records.

Responsibilities

• 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.
• Providing role-based new Employee Training.
• Supporting audits by reviewing documents for accuracy and compliance.

Skills

Communication skills

Attention to detail

Tools

Microsoft Excel

Job description

Granules Pharmaceuticals, Inc. is seeking a QA Documentation Specialist to support batch release and record review in SAP. The role covers labeling, carton release, sampling, inspection, and documentation uploads to SAP Portal, with weekly batch release reporting and change-control coordination.

Candidate will prepare annual product reviews, submit data for FDA submissions, and assist with employee training. Experience in GMP environments and strong Excel skills are preferred.