QC Sample Coordinator I

Summary of Objective

This position will have responsibility for supporting activities in the QC Sample Management group. The Coordinator I is responsible for coordinating testing and transfer of samples both internally within PCI and with external contract laboratories, receipt and processing of critical production and raw material samples, management of proprietary client material for use as reference standards in the QC Laboratory, and ordering & receiving chemicals for laboratory use. This position will involve review of internal and external specifications, validation protocols, contract laboratory reports, and final reconciliation / close out of materials prior to submission to QA Document Control for long term filing. Additionally, this position will conduct dimensional testing of incoming container and closure samples with the use of calibrated instrumentation to support raw material release.

This position includes work in the laboratory, requiring the use of PPE, including gloves, lab coat, safety glasses.

Essential Duties and Responsibilities

• Ordering, receipt and management of QC Laboratory supplies, including chemicals and consumable materials in accordance with cGMP and procedural requirements.
• Monitoring, ordering and maintenance of the primary QC laboratory supply KANBAN system.
• Receipt of reference standards from internal teams, clients and external suppliers, including review of documentation to meet internal requirements.
• Management of the reference standard inventory, including communication with internal project management teams to request additional client supplied materials and updated documentation for materials currently in inventory.
• Inspection, review and receipt of incoming samples for testing in the QC laboratory and/or contract laboratories. Verification of information against specifications, protocols and other documentation to ensure accurate material receipt and compliance.
• Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements.
• Complete data entry in validated systems and business tools with a high degree of accuracy.
• Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing.
• Coordinating testing with external contract laboratories. Request quotes and POs as needed, and coordinate with project management for client managed testing.
• Provide documentation and samples to the materials management team to process for shipment.
• Review and reconcile completed testing packets prior to submission to QA Document Control for long term storage.
• Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements.
• Perform dimensional inspections on containers and closures materials in quarantine.
• Assist with sampling container and closure materials as needed.

Special Demands

• Must be able to walk and drive between local sites
• Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
• Must be comfortable working with and handling hazardous materials
• Must be able to climb stairways and use stepstools
• Must be able to lift and move boxes weighing 40lbs

Work Environment

Laboratory, office, warehouse