30 days old

Sr. QC Analyst

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    122889145
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The Sr. QC Analyst will support product testing (release, stability, and in-process samples) for both clinical and commercial activities within the Quality Control environment. Review laboratory documentation for accuracy, participate with the team to meet group goals and perform routine laboratory duties. Author quality records such as laboratory investigations, deviations and CAPAs. Participate in the preparation of investigations, summaries and reports as needed.

Essential Duties/Responsibilities
  • Perform routine and non-routine release, stability, and in-process samples testing and documentation under cGMP.
  • Review laboratory records generated in support of QC testing including procedures, methods, and other controlled documents
  • Author quality records such as laboratory investigations, deviations and CAPAs, including leading thorough and timely investigation activities.
  • Maintain laboratory space to regulatory expectations and internal procedures on a regular basis
  • Provide training to laboratory analysts, as needed.
  • Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.


Education
  • Requires a Bachelor of Science in Biochemistry, Biology or a related pharmaceutical-biotechnology discipline. Master of Science in related field is highly desired.


Experience
  • A minimum 5 years work experience within a GMP environment working with peptides and proteins.
  • Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC/UPLC chromatography, including Waters Empower software is required.
  • Solid experience in the development, optimization and validation of analytical techniques is highly desirable.
  • Solid technical training and troubleshooting experiences are essential.


Knowledge, Skills and Abilities
  • Knowledge of cGMP requirements and ICH guidelines.
  • Excellent interpersonal and communication skills in a team-oriented environment are required.
  • Strong critical thinking and problem solving skills.
  • 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.
  • Proficient in the use of Microsoft Word and Excel
  • Experience with statistical software such as JMP




PI122889145

Categories

Posted: 2020-08-22 Expires: 2020-09-22

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Sr. QC Analyst

Revance Therapeutics Inc.
Newark, CA 94560

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