Quality Control Analyst II
Company: Joulé
Location: Piscataway
Posted on: June 29, 2025
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Job Description:
Job Title: QC Analyst II Location: Piscataway, NJ
Hours/Schedule: M-F, 8:30 am – 5:00 pm (May require extended hours
or weekends during manufacturing runs) Type: Direct Hire /
Permanent Overview We are seeking a QC Analyst II with a strong
background in small molecule and protein chemistry to support our
client’s QC laboratory in a cGMP-compliant environment. The role
involves analytical testing and data verification to support both
late-stage clinical and commercial products, including biosimilars.
The ideal candidate will be skilled in troubleshooting analytical
results and working with cross-functional teams on projects,
process improvements, and laboratory investigations.
Responsibilities Perform analytical testing and data verification
to support in-process, release, raw materials, and stability
programs. Conduct testing using HPLC, SDS-PAGE, cell-based
bioassays, capillary electrophoresis, and ELISA. Collaborate across
departments to resolve project issues, conduct lab investigations,
and implement process improvements. Document and investigate Out of
Specification results, deviations, and implement corrective
actions. Support regulatory inspections and prepare dossiers for
agency interactions. Maintain laboratory equipment and comply with
all company policies, standards, and regulatory guidance.
Requirements Bachelor’s degree in Biotechnology, Biochemistry,
Chemistry or related field with a minimum of 8 years of QC
experience in pharma / biotech. OR Master’s Degree in the above
fields with 6 years of QC experience in pharma / biotech Prior
experience in a cGMP laboratory is essential Strong knowledge in
protein and small molecule chemistry and proficiency with
techniques such as HPLC, SDS-PAGE, ELISA, and capillary
electrophoresis Experience with SOPs, QC methods, and regulatory
dossiers Demonstrated ability to support regulatory inspections
(e.g. PAI) Working Environment Primarily lab-based with some office
work for documentation Must be able to lift 25 lbs Travel up to
5%-10% as needed (between Piscataway and South Plainfield
locations) Benefits System One offers eligible employees health and
welfare benefits coverage options, including medical, dental,
vision, spending accounts, life insurance, voluntary plans, and
participation in a 401(k) plan. M3 Ref: 558-Scientific
Keywords: Joulé, Hamilton , Quality Control Analyst II, Science, Research & Development , Piscataway, New Jersey
