QC Analytical Specialist II
About The Position
Kite is seeking a QC Analytical Specialist II to perform quality control testing and support laboratory operations for biopharmaceutical products. The role performs analytical testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. It supports data monitoring and trending, record review, product-release documentation, laboratory instrument maintenance, documentation authoring, investigations, GMP compliance, and continuous improvement. The position is designated as an overnight shift; the listed schedule is Saturday 11:30 PM through Wednesday 10:00 AM. Potential shifts may also be Sunday–Wednesday or Wednesday–Saturday, and business needs may require an alternate work schedule. The position requires an MS degree, or an alternative combination of education and experience: a bachelor's degree plus 3 or more years of biotechnology or related-field experience and Quality Control experience; an associate degree plus 5 or more years of such experience and Quality Control experience; or a high school degree plus 7 or more years of such experience and Quality Control experience. Preferred qualifications include knowledge of GMP and quality control, experience with investigations and out-of-specification results, analytical methods used in biopharmaceutical testing, and familiarity with relevant quality systems and regulatory requirements.
Requirements
- One of the following education and experience combinations: MS degree; bachelor's degree plus at least 3 years of biotechnology or related-field experience and Quality Control experience; associate degree plus at least 5 years of biotechnology or related-field experience and Quality Control experience; or high school degree plus at least 7 years of biotechnology or related-field experience and Quality Control experience.
Nice To Haves
- Thorough knowledge of GMP, SOPs, and quality control processes.
- Experience identifying, writing, evaluating, and closing OOS results and investigations.
- Proficiency in MS Word, Excel, PowerPoint, and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific and technical personnel.
- Knowledge of analytical techniques such as flow cytometry, ELISAs, PCR, and cell bioassays, as well as other applicable methods for testing biopharmaceuticals.
- Working knowledge of quality systems and regulatory requirements, including 21 CFR Parts 11, 210, and 211.
- Experience in the biotechnology and/or pharmaceutical industry.
Responsibilities
- Perform testing of raw materials, intermediates, and final products using analytical methods including cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
- Work with internal and external resources to maintain the laboratory in an optimal state.
- Assist with monitoring and trending data and complete routine review of test data and related records for in-process testing and drug substance and drug product release.
- Supply information to support generation of Certificates of Analysis (CoAs) for product release.
- Maintain laboratory instruments through calibration and routine maintenance.
- Author or revise SOPs, qualification and validation protocols, and reports.
- Assist with laboratory investigations regarding out-of-specification (OOS) results and participate in determining root causes for deviations related to analytical procedures.
- Provide updates at daily and weekly meetings.
- Monitor existing GMP systems to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metrics for continuous improvement in areas of responsibility.
- Perform other duties as required.
Benefits
- Potential eligibility for a discretionary annual bonus.
- Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical insurance.
- Company-sponsored dental insurance.
- Company-sponsored vision insurance.
- Company-sponsored life insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
