QC Analyst II

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Job description

Kelly Scientific is seeking a QC Analyst II in Chicago, IL (near Bridgeport neighborhood).

Direct Hire

Shift: Monday - Friday 8:30am-5pm

Compensation: $60K-$70K/year DOE

Position Summary

The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories, and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of company's Quality Systems.

Essential Duties & Responsibilities

• Analytical testing to support product in-process, release, and stability programs.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
• Train other analysts to perform laboratory procedures and assays. Participate in internal assessments and audits as and when required.
• Complies with all company policies and standards.
• Other duties as assigned.

Education:

• Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas with 3 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.

Experience:

• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.

Special Skills:

• Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
• Previous experience supporting regulatory inspections (e.g. PAI).
• Familiarity with preparing regulatory dossiers and data packages for interactions between Adello and regulatory agencies.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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