8 days old

Sr. QC Analyst

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    124859535
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

Works closely with members of the QC Microbiology teams within the manufacturing and laboratory settings. Responsible for the coordination and execution of environmental monitoring of plant utilities and production clean zones, as needed. Review laboratory documentation for accuracy, participate with the team to meet group goals and perform routine laboratory duties. Lead excursion investigations, coordinate summaries and reports as needed. Lead EM deviation investigations, manage EM corrective and preventative actions, lead EM change controls/ requests. Manage incoming laboratory supply program, coordinate media preparation, and maintenance of laboratory inventories. Ensure equipment is appropriately maintained and calibrated. Originate and revise standard operating procedures. Lead special projects with microbiological assays and/or instrument problem solving as needed.

May perform and coordinate microbiological and/or chemical analyses of plant utilities, in-process, product and raw material testing to ensure product quality and stability. Provide support during method development, qualification, validation and method transfer studies following approved protocols.

Essential Duties/Responsibilities
  • Coordinate and lead execution of environmental monitoring sampling and analysis of plant utilities and production clean zones using particle counters, contact plates, and microbial air samplers.
  • Leads EM support of aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance
  • Performs enumeration, characterization, and speciation of microorganisms recovered from samples
  • Regularly apply basic theory and principles from one's expertise in microbial characterization and cGMP to develop and trend seasonal flora populations within the manufacturing area.
  • Manage and lead laboratory and environmental excursion investigations supporting quality systems.
  • Prepare trend analysis reports for management review.
  • Provide lab maintenance and support to ensure cGMP compliance on a regular basis.
  • Take full responsibility in reviewing data packets, test procedures, SOPs and other controlled documents in a detailed and accurate fashion.
  • Originate and revise procedural SOPs.


Education

Minimum Required:
  • High School Diploma


Preferred:
  • B.S. or M.S.


Experience

Minimum Required:
  • A minimum 8-12 years of related work experience within GMP environment.
  • Experience with aseptic manufacturing principles and microbiological methods.
  • Previous cGMP, solid technical training and troubleshooting experiences are required.
  • Experience with quality systems investigations.
  • Experience in the development, optimization, and validation of assays.


Preferred:
  • Experience with cell based assays.


Knowledge, Skills and Abilities

Minimum Required:
  • Excellent interpersonal and communication skills in a team environment
  • Proficient written and verbal communication


Preferred:
  • Ability to work independently as well as within a team setting, handle multiple projects, demonstrate initiative and accountability, strong attention to detail




PI124859535

Categories

Posted: 2020-10-14 Expires: 2020-11-14

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Sr. QC Analyst

Revance Therapeutics Inc.
Newark, CA 94560

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