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QC Analyst II (Contract)

Company: Revance
Location: Newark
Posted on: June 6, 2021

Job Description:

Position Summary:

The Analyst II will support product testing (release, stability, and in-process samples) for both clinical and commercial activities within the Quality Control environment. Author phase appropriate protocols and reports for transfer and validation of test methods including execution and establishment of test methods within Quality Control. 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 Functions:

  • Perform routine and non-routine release, stability, and in-process sample testing and documentation under cGMP.
  • Perform method transfer of test methods from development to Quality Control, including authoring of protocols and reports.
  • Conduct phase-appropriate method validation, including authoring of protocols and reports.
  • Establish test methods for the analysis of the release, stability, and in-process samples, including defining preparation, qualification, and requalification requirements for critical reagents and reference standards.
  • Review laboratory records generated in support of QC testing, including procedures, methods, audit trails and other controlled documents
  • Author quality records such as laboratory investigations, deviations, CAPAs and change controls, including leading thorough and timely investigation and/or implementation 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.

Preferred Experience:

  • A minimum 3-5 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 preferred.
  • Experience in performing data audit trail review and a strong understanding of data integrity principles within a GMP environment.

Preferred Education:

  • Requires a Bachelor of Science in Biochemistry, Biology or a related pharmaceutical-biotechnology discipline.

Preferred Additional Skills:

  • 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

We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Keywords: Revance, Newark , QC Analyst II (Contract), Other , Newark, California

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