Job Description

Senior Quality Control Analyst needed!

This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200), cell-based potency assays utilizing various immunoassays (ELISA, ELLA, etc.) platforms, and/or identification / characterization / potency assays using multicolor flow cytometry platforms. This position will support the onboarding of new or updated assays for the QC analytical team and other activities in a newly built facility for cell therapy products. This position works across different shifts. Depending on your assigned shift, you may be required to work weekends and holidays to complete assigned work.

Essential Functions and Responsibilities:

• Collaborate effectively with Development and ASAT teams to perform assay co-qualification, validation, and technical transfer of updated and new assays, as well as potential new products.
• Act as subject matter expert (SME) and train laboratory personnel on assays.
• Perform all activities with respect to GMP/GDP compliance.
• As needed to support production, perform GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Support thorough GMP investigations for quality events.
• Author, review, and approve technical assay documents including but not limited to protocols, reports, and procedures.
• Support technical problem solving for issues pertaining to GMP Quality Control.
• Assist in the generation and revisions and review of documentation, such as SOP, protocols and reports.
• Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls.
• Perform technical review of laboratory data and logbooks.
• Operate at a consistent and high level of efficiency, producing high quality and accurate results.
• Support Health Authority inspections.
• Provide input to functional laboratory team meetings.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Other responsibilities, as assigned.

Required Education, Skills, and Knowledge:

• Bachelor’s degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field or equivalent combination of education and experience.
• Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control or related role
• Solid understanding and functional knowledge with hands-on experience with two (2) or more of the following: Multicolor Flow Cytometry, Cell-based ELISA, cell culture with cell enumeration (NC-200)
• Experience in technical writing (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.)
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills.
• High level of ownership and accountability.
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

Preferred Education, Skills, and Knowledge:

• Experience with cell therapy products is a plus and/or relevant technical skills (NC 200, ELISA, and/or Flow).

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear all appropriate Personal Protective Equipment (PPE), including but not limited to: lab coat, half face respirator as applicable, safety glasses/goggles, and nitrile gloves.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 20 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

• This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.

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