Senior Specialist, Sample Management QC

About the role

QPS has an immediate opening for a Senior Specialist, Sample Management QC within the Translational Medicine Department. This role is 100% desk-based and involves performing QC activities through document review, data verification, and system-based checks. No laboratory or hands-on QC testing is required.

Responsibilities

• Create and maintain Sample Receipt notebooks from creation to archival
• Use LIMS (database) for tracking of samples through their life cycle at QPS
• Perform QC of Sample Receipt records against an electronic database to ensure compliance with FDA and GLP regulations, client protocol, and QPS SOPs
• Avoid any discrepancies in Sample Receipt records by ensuring all appropriate GLP paperwork is included with sample receipt packets
• Verify that shipped samples are received and reconciled according to client protocol and shipping manifests
• Communicate any referenced client correspondence to verify its accuracy
• Maintain TLM Sample Receipt Table Request log and address any timeline issues internally to the Principal Investigator
• Compile and/or perform QC on Sample Receipt tables prior to submission to QA
• QC various Data Management generated reports prior to submitting to Principal Investigator
• Assist Sample Management Team with general documentation questions
• Reconcile shipment packets against TLM Dashboard
• Communicate any new SOP revisions to the team and reconcile Employee Qualification Manuals annually
• Understand and adhere to HIPAA & GDPR compliant privacy measures

Requirements

• University/college degree in a relevant scientific discipline or demonstrated experience in a CRO, Clinical Research, or another relevant field
• Experience in an FDA-related or other regulated industry laboratory is preferred
• Organized with good detail-orientation
• Proficiency with MS Office, including Excel
• Good interpersonal skills