Coordinator QC Lab

Incyte · Yverdon-les-Bains

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SUMMARY

The QC Lab Coordinator supports the activities of the Quality Control department with missions related to administrative tasks such as documentation management and reconciliation, lab reagents/consumables purchase, related goods receipt, sample/material shipment arrangement, invoices reconciliation, production samples reception and aliquoting, technical support on sample physico-chemical analysis.

DUTIES AND RESPONSABILITIES

• Management of QC samples coming from Manufacturing: reception, aliquoting, record in LIMS, storage, shipment to third part laboratories, …
• Purchase Request management: request for quotation, PO creation, good receipt, invoice reconciliation (materials, equipment, services)
• Reagents/consumables management: tracking, receiving, labeling, inventory, kanban, purchase order, coordination of release process with QA and record in LIMS,
• Follow-up of goods delivery: point of contact and inter-departmental coordination
• Documentation support: management of controlled copies, document conformity review, document approval in the quality system, archiving.
• Author, review and maintain life cycle of relevant Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required
• Ensure efficient communication within Quality Control teams and with Manufacturing, Supply Chain, Warehouse, Quality Assurance, and External Service Providers
• May contribute to health authorities’ inspection, internal and corporate audit, response to observation
• May contribute to basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.).
• Contribute positively to a strong culture of business integrity and ethics
• Act in accordance with legal and compliance requirements and company guidelines
• May contribute to quality events management (deviations, investigations, CAPA, Change control, …)
• Max perform some simple QC analysis to support production release of drug substance (nice to have)

REQUIREMENTS

• Diploma (CFC, License, or BTS etc.) in analytical chemistry, commercial or administrative management or any equivalent experience of one to three years in similar functions in the chemical, pharmaceutical or biotechnology industry
• Strong experience in a GMP environment, in a pharmaceutical or biotechnology company
• Strong knowledge and respect for safety rules related to laboratory work
• Ability to work in a highly regulated and fast changing environment
• Highly developed team spirit
• Proactivity and pragmatism
• Rigorous and organized
• Be able to make proposals
• Language: French (fluent) and English (written; spoken preferred)

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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