Quality Control Analyst III
Company: Revance
Location: Newark
Posted on: June 22, 2022
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Job Description:
Position Summary:The QC Analyst III will support product testing
(release, stability, and in-process samples) for both clinical and
commercial activities within the Quality Control environment
including analytical and cell-based assays. 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 cell-based potency assays release and stability
testing under cGMP including management of the cell bank. ---
Conduct phase-appropriate method validation including authoring of
protocols and reports. --- 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
including support of equipment qualification and onsite vendor
support. --- Provide training to laboratory analysts, as needed.
Guide junior analysts in the laboratory environment including
troubleshooting. --- Work collaboratively with Manufacturing, QA
and Regulatory to support CMC analytical deliverables.Preferred
Experience:--- A minimum 4 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. --- Experience with cell-based methods and aseptic
technique. --- Technical training and troubleshooting experiences
are 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. Master of Science in
related field is highly desired.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 --- Experience
with statistical software such as JMPWORK ENVIRONMENT & PHYSICAL
DEMANDSThis section of the job description is required by the
American with Disability Act, (ADA). The ADA requires that job
descriptions reflect the physical and mental demands required to
effectively perform the essential duties of the job. The ADA
prohibits employers from discriminating against a "qualified
individual with a disability" in all aspects of the employment
relationship. A "qualified individual with a disability" is "an
individual who meets the education, experience, skill, and other
job-related requirements of a position held or desired, and who,
with reasonable accommodation, can perform the essential functions
of a specified job."
Keywords: Revance, Newark , Quality Control Analyst III, Professions , Newark, California
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