Sr. QC Analyst (Biosimilar)
Posted on: May 31, 2021
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. 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.
This position is dedicated to support the Biosimilar project.
- 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 analysis of the Biosimilar product
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.
- Requires a Bachelor of Science in Biochemistry, Biology or a
related pharmaceutical-biotechnology discipline. Master of Science
in related field is highly desired.
- 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
- Experience in performing data audit trail review and a strong
understanding of data integrity principles within a GMP
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
- Proficient in the use of Microsoft Word and Excel
- Experience with statistical software such as JMP
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 , Sr. QC Analyst (Biosimilar), Other , Newark, California
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