Lab Ops Specialist I - Quality Control

Job Description

We are seeking a highly motivated individual to join us as a Lab Ops Specialist I. This position provides Quality Control testing of clinical and commercial product, responsible for raw material testing, in-process and final product testing.

Responsibilities

• Perform testing of raw materials, intermediates and final products by following analytical methods
• Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA, qPCR and ddPCR assays
• Track and test products according to Stability protocols. Compile stability protocols data and review to ensure
• Work with internal and external resources to maintain lab in an optimal state
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies
• Revise and review SOPs, qualification/validation protocols and reports
• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.  Provide updates at daily and weekly meetings.
• Perform on-the-job training and Instructor-Led training for other staffs
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Help review proposed changes to systems, procedures, methods, and submissions to regulatory agencies
• Gather metric information, analyze and provide recommendation for continuous improvement of areas of responsibility
• Perform other duties as assigned

This position will work day shift Wednesday-Saturday 6:30am-5pm.

Basic Qualifications

Bachelor’s Degree

OR

AA Degree and 2+ years’ experience in Quality Control

OR

High School Degree and 3+ years’ experience in Quality Control

Preferred Qualifications

• Degree in biotechnology or related field with Quality Control experience
• Strong knowledge of GMP, SOPs and quality control processes
• Experience identifying, writing, evaluating and closing laboratory (OOS) 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)
• Experience in the biotech and/or pharmaceutical industry