9 days old

QC Raw Material Supervisor

Revance Therapeutics Inc.
Newark, CA 94560
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  • Job Code
    126209930
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The QC Raw Material 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
  • Maintain raw material program in compliance with regulatory requirements and commitments for clinical and commercial products.
  • Work in a cross-functional team to ensure raw material disposition in a timely manner for the continued support of manufacturing operations.
  • Maintain existing and perform qualification of new raw material suppliers including documentation 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; report, manage and investigate non-conforming and out-of-specification results in timely manner to ensure appropriate immediate actions are taken.
  • Ensure raw material equipment and sampling facilities are appropriately validated, calibrated and maintained.
  • Perform raw material sampling including QA retains and testing to internal specifications.
  • Manage development and validation of non-compendial test methods for raw material release, as needed
  • Will supervise and guide raw material coordinator.


Education

Minimum Required:

BS in Biochemistry, Chemistry or related Sciences

Experience

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.


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




PI126209930
Posted: 2020-11-18 Expires: 2020-12-20

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QC Raw Material Supervisor

Revance Therapeutics Inc.
Newark, CA 94560

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