QC Sample Specialist — Drive Lab Coordination & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 45,000 - 60,000; Full time

Job summary

PCI Pharma Services is seeking a QC Sample Coordinator I to support the QC Sample Management group. You will coordinate testing and transfer of samples internally and with external contract laboratories, manage reference standards, and handle ordering of chemicals for lab use.

The role includes reviewing specifications, validation protocols, contract laboratory reports, and final file reconciliation, plus maintaining chain of custody and conducting dimensional testing to support raw material

Qualifications

• High school diploma required; Associate’s or Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related field) preferred.
• Proficient in MS Office.
• Must have strong attention to detail as well as ability to work in a cross-functional team environment.
• Professional interpersonal skills and the ability to communicate well orally and in writing.
• Ability to multi-task in a dynamic environment with changing priorities.
• Ability to work independently as well as on a team, with limited supervisory oversight.
• Master Control or equivalent experience working with a validated document system preferred.
• Basic understanding of cGMP, GDP, and laboratory workflows preferred.
• Laboratory experience and familiarity with chemical handling preferred.

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.

Skills

Attention to detail

Cross-functional teamwork

Oral and written communication

Independent and team worker

Education

High school diploma required

Associate’s or Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related field) preferred

Tools

MS Office

Job description

PCI Pharma Services is seeking a QC Sample Coordinator I to support the QC Sample Management group. You will coordinate testing and transfer of samples internally and with external contract laboratories, manage reference standards, and handle ordering of chemicals for lab use.

The role includes reviewing specifications, validation protocols, contract laboratory reports, and final file reconciliation, plus maintaining chain of custody and conducting dimensional testing to support raw material