KB QC Analyst II

Amneal • Chicago, IL

1d

About The Position

The Quality Control Analyst II performs analytical testing and data verification for late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. The role also contributes to continuous improvement initiatives intended 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 and assays. The position collaborates across departments to support timely resolution of projects, laboratory investigations, and process improvements.

The work includes time in both an office and a laboratory, with a significant amount of time spent in the laboratory. Extended or weekend hours may be requested, and some travel may be required. The role operates in a high-paced environment structured to meet ambitious project goals and requires the ability to work under pressure and meet deadlines.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 3 years of experience in a pharmaceutical or biotech QC laboratory; alternatively, a relevant master’s degree and 2 years of experience, or a relevant PhD and at least 1 year of experience.
• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success writing and revising SOPs, protocols and reports, and QC methods, and complying with them.
• Demonstrated success working with HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• Ability to work extended or weekend hours as requested.
• Ability to lift at least 25 lbs.
• Ability to work under pressure and meet deadlines.

Nice To Haves

• Previous experience supporting regulatory inspections, such as PAI.
• Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.

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 preventative action plans.
• Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
• Train other analysts to perform laboratory procedures and assays.
• Participate in internal assessments and audits as required.
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level