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QC Supervisor

Company: Revance
Location: Newark
Posted on: May 31, 2021

Job Description:

Position Summary

The QC Supervisor will be responsible for improvement, development, implementation and maintenance of the raw material program and internal procedures and processes in compliance with regulatory requirements and commitments for clinical and commercial products. The individual will work closely with a cross-functional team (e.g. Manufacturing, Quality Assurance, Supply Chain, etc.) and external laboratories to ensure testing completion and review and approve the results.

The position is part of the Federal Select Agent Program. All individuals who work with these agents will undergo and be required to successfully complete a Security Risk Assessment that is performed by the Federal Bureau of Investigation/Criminal Justice information services.

Essential Duties/Responsibilities

* Manage and maintain raw material program in compliance with regulatory requirements and commitments for clinical and commercial products. * Review and approve raw material specifications in accordance with regulatory requirements and internal procedures. * Ensure timely raw material sampling (QC samples and QA retains) and testing to support QA disposition for the continued support of manufacturing operations; communicate potential delays or issues to cross-functional team. * Manage and maintain the raw material qualification process, including evaluation of new suppliers in accordance with internal procedures. * Manage contract testing laboratories for testing of raw materials within turnaround times to ensure on time disposition of materials * Review and approve raw material results against material specifications; report, manage and investigate internal or external out-of-specification results in timely manner to ensure appropriate immediate actions are taken. * Responsible for investigating non-conforming raw materials, in collaboration with Quality Assurance and Supply Chain. * Ensure raw material equipment and sampling facilities are appropriately validated, calibrated and maintained. * Manage development and validation of non-compendial test methods for raw material release, as needed * Will supervise and guide raw material coordinator.


Minimum Required:

BS in Biochemistry, Chemistry or related Sciences


Minimum Required:

5+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in a QC senior analyst role supporting raw material program

Knowledge, Skills and Abilities

Minimum Required:

* Proven strong interpersonal, organization and problem-solving skills * Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to raw materials * Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment * Knowledge of analytical, micro and protein methods is strongly preferred.


* Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines * Experience with preparing regulatory documentation and inspection management

Keywords: Revance, Newark , QC Supervisor, Other , Newark, California

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