Qc Analyst I Jobs

The Quality Control Analyst I 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 Kashiv’s Quality Systems.

A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

Essential Duties & Responsibilities

• Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
• Performs other functions as required or assigned
• Knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Analytical testing to support product in-process, release, and stability programs.
• A commitment to Kashiv’s Vision, Mission, and Values is essential.
• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Complies with all company policies and standards

Education:

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 2 years of experience in a pharmaceutical/biotech QC laboratory.
• Alternatively, Master’s degree in above areas with 1 year of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas.

Special Skills:

• Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.

Work Environment & Physical Demands:

• Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
• High-paced environment structured to meet ambitious project goals
• Ability to work under pressure and meet deadlines.
• Significant amount of time spent in the laboratory.
• Some travel may be required
• Must be able to lift at least 25 lbs.
• Must be able to work extended hours or weekend hours as requested.

Supervisory Responsibility, if any: No

Benefits/Perks:

• 401K
• < 10 minutes away from Downtown Chicago
• On-site Gym
• Dental
• Student Loan Assistance
• Vision
• Medical
• One block east of the Chicago White Sox Stadium
• Monthly Cell Phone Allowance
• FSA - Commuter/Transit
• Conveniently located next to the Metra, Green and Red Line
• Free Parking (Company Paid)

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.