Pharma Batch Record Compliance Reviewer

Sharp Services, LLC

Northern (KY)

Hybride

USD 45 000 - 60 000

Plein temps

14 jours+

Générateur de candidature

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Résumé du poste

Sharp Services, LLC in Kentucky is seeking a detail-focused documentation reviewer to ensure packaging documents are compliant and ready for distribution. You will review primary, secondary, and clinical packaging records, log findings, and address customer inquiries related to documentation and compliance.

The role supports FDA cGMP knowledge, QA audits, and collaboration with Quality, Project Management, and Operations.

Qualifications

Excellent detail skills as they apply to documentation review and compliance.
Good written and oral communication skills.
Good organizational and planning skills.
Excellent interpersonal skills are required.

Responsabilités

Review documentation related to primary, secondary, and clinical packaging after reconciliation.
Log and log all documentation for errors, omissions, and compliance with cGMPs and SOPs.
Follow up on customer inquiries related to packaging documentation and compliance.
Perform final release of in-process or finished product.
Maintain QAD Item Master and Router Maintenance.
Log and maintain packaging process samples and coordinate shipment of samples to customers.
Enter lot-specific information into the Quality Dashboard.
Participate in internal, customer, and regulatory audits as required.
Other duties as assigned.