QC Analyst II (Contract)
Posted on: June 6, 2021
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.
- 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
- 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.
- 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
- Experience in performing data audit trail review and a strong
understanding of data integrity principles within a GMP
- 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
- 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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