KB QC Analyst II
About The Position
The Quality Control Analyst II performs analytical testing and data verification supporting 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 important for performing and troubleshooting analytical techniques, and the position requires collaboration across departments to resolve projects and laboratory investigations and support process improvements. The analyst performs testing for in-process, release, and stability programs; applies knowledge of cGMP, Quality Systems, and ICH and regulatory guidance; and conducts, compiles, or reviews out-of-specification investigations, deviations, and corrective and preventive action plans. The role also supports cross-functional projects, equipment maintenance, document and report authoring, analyst training, assessments, and audits. Other functions may be assigned, and the employee must comply with company policies and standards. The work includes time in an office reading, writing, reviewing, and editing documents, as well as a significant amount of time in a laboratory. Extended or weekend hours may be requested, some travel may be required, and the role involves working under pressure and meeting deadlines in a high-paced environment.
Requirements
- Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 3 years of experience in a pharmaceutical or biotechnology 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, revising, and complying with SOPs, protocols, reports, and QC methods.
- Demonstrated success using techniques such as 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 supporting product in-process, release, and stability programs.
- Apply knowledge of cGMP, Quality Systems, and ICH and regulatory guidance.
- 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 and maintain equipment.
- 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 company policies and standards.
Benefits
- Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
- Comprehensive, flexible, and competitive benefits program for eligible positions.
- Health and insurance benefits.
- 401(k) matching contribution.
- Employee well-being programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
