Lab Ops Specialist

Position: Lab Ops Specialist I
* Perform testing of raw materials, intermediates, and final products by following analytical methods:
Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
* Work with internal and external resources to maintain lab in an optimal state.
* Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
* Maintains laboratory instruments for calibration and routine maintenance
* Author or revise SOPs, qualification/validation protocols and reports.
* Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
* Provide updates at daily and weekly meetings.
* Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
* Gather metric information for use in continuous improvement of areas of responsibility.
* Perform other duties as required.
* Bachelor’s Degree OR
* AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR
* High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience
* Thorough knowledge of GMP, SOPs and quality control processes.
* Identifying, writing, evaluating, and closing OOS’s and investigations.
* Proficient in MS Word, Excel, Power Point and other applications.
* Strong written and verbal communication skills.
* Ability to communicate and work independently with scientific/technical personnel.
* Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
* Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
* Preferred:
Experience in the biotech and/or pharmaceutical industry.
* Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
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