QC Analyst II - Newark, CA | Biospace
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QC Analyst II

Revance Therapeutics, Inc.

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Location:
Newark, CA
Posted Date:
6/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Analyst, QC, Quality, Quality Control,

Job Description


Works closely with members of the Environmental Monitoring team in both a manufacturing and laboratory environment.  Responsible for performing and coordinating a variety of microbiological and chemical sampling in support of the environmental monitoring within controlled manufacturing areas, production clean zones, laboratories and from plant utilities to demonstrate these areas are maintained in a state of control. Coordinate and perform microbiological and chemical analysis in support of cleaning verification of processing equipment between production lots. Review laboratory documentation for accuracy, participate with the team to meet group goals and perform routine laboratory duties. Participate in the preparation of investigations, summaries and reports as needed.  Revise and update standard operating procedures as needed.  May participate in special projects within microbiological and instrument problem solving

Essential Functions:

•   Responsible for performing environmental monitoring of plant utilities and production clean zones using particle counters, contact plates and mirobial air samplers.
•   Support aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance
•   Performs enumeration and characterization 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.
•   Aide in excursion investigations, trend analysis and non-conformance resolutions in support of the corrective/preventative action program
•   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.
•   Participate in the writing and revising of procedural SOPs

Requirements


Preferred Experience:

•   A minimum 2-5 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 in the development, optimization and validation assays is a plus.

Preferred Education:

•   Bachelor’s degree or equivalent experience.

Preferred Additional Skills (i.e., Computer):

•   Excellent interpersonal and communication skills in a team-oriented environment are required.
•   Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.
•   Proficient written and verbal communication skills are required.