14 days old

Quality Assurance Specialist III

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    126296913
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The Quality Assurance Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimum supervision, the individual will be working primarily in quality operations providing quality assurance support to CMC teams and to in-house DS and DP production, testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, and Manufacturing departments.

Essential Duties/Responsibilities
  • Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development and commercial manufacturing
  • Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components etc.)
  • Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports
  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
  • Perform retain sampling and support the reserve sample program
  • Perform area approval, line clearance and product inspection
  • Perform product complaints investigations
  • Actively update department databases to ensure up-to-date reporting of metrics
  • Support continuous improvement of quality operations and department databases; author new, revise existing and may review department procedures and/or forms
  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
  • Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
  • Assist in data verification of DS and DP sections of regulatory submissions as needed
  • Assist in the internal compliance audits as needed


Education

Minimum Required:

BS or equivalent in biology, chemistry or related science

Experience

Minimum Required:
  • Minimum 4-6 years experience in the pharmaceutical or biotechnology industry with at least 4 years working in direct manufacturing or performing quality functions; experience in aseptic manufacturing processes is highly desirable
  • Ability to work with all levels cross-functionally
  • Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents


Preferred:
  • 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 years working quality operations involving aseptic fill, finish, and packaging operations


Knowledge, Skills and Abilities
  • Excellent interpersonal and verbal and written communication skills
  • Good working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP
  • Works independently with minimum supervision to accomplish goals
  • Relies on extensive experience and judgment to resolve simple to moderately complex issues
  • Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments
  • Prior experience with regulatory inspections is desired

Please Note: You will be required to successfully complete a Security Risk Assessment (SRA) via the CDC



PI126296913
Posted: 2020-11-20 Expires: 2020-12-21

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Quality Assurance Specialist III

Revance Therapeutics Inc.
Newark, CA 94560

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