KB QC Analyst I

Amneal•Chicago, IL

About The Position

The Quality Control Analyst I performs analytical testing and data verification in cGMP-compliant laboratories to support late-stage clinical and commercial biosimilar products. The role also participates in continuous improvement initiatives to improve the efficiency and effectiveness of Kashiv’s Quality Systems. A strong background in protein chemistry is essential for performing and troubleshooting analytical techniques. The position requires collaboration across departments to support timely project resolution, laboratory investigations, and process improvements. The role includes work in both an office and laboratory setting, with significant time spent in the laboratory. Extended or weekend hours may be requested, and some travel may be required. The position requires the ability to lift at least 25 pounds and to work under pressure and meet deadlines in a fast-paced environment with ambitious project goals. The stated salary range is $68,000–$85,000 per year. The position also offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible positions have access to a flexible benefits program, including health and insurance benefits and a significant 401(k) matching contribution.

Requirements

  • Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 2 years of experience in a pharmaceutical or biotechnology QC laboratory; alternatively, a master’s degree in one of these fields and 1 year of relevant QC laboratory experience, or a PhD in one of these fields.
  • Demonstrated success with HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
  • Knowledge of cGMP, Quality Systems, and ICH/regulatory guidance.
  • Strong background in protein chemistry.
  • Ability to collaborate across departments to resolve projects, laboratory investigations, and process improvements in a timely manner.
  • Ability to work under pressure and meet deadlines.
  • Ability to lift at least 25 pounds.
  • Ability to work extended or weekend hours when requested.

Responsibilities

  • Perform analytical testing to support product in-process, release, and stability programs.
  • Conduct, compile, and/or review out-of-specification laboratory investigations, deviations, and corrective and preventive action plans.
  • Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
  • Participate in continuous improvement initiatives for Quality Systems.
  • Comply with company policies and standards, and uphold Kashiv’s Vision, Mission, and Values.
  • Perform other functions as required or assigned.

Benefits

  • Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
  • Flexible benefits program for eligible positions.
  • Health and insurance benefits.
  • 401(k) matching contribution.
  • Employee well-being programs.
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