Qc Analytical Lab Ops Specialist I

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

****NOTE: shift is Wed-Sat 1300-2330 ****

Responsibilities (include but are not limited to):

• 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.
• 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.
• Work with internal and external resources to maintain lab in an optimal state.
• Maintains laboratory instruments for calibration and routine maintenance
• Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
• 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.
• Perform other duties as preferred.
• Provide updates at daily and weekly meetings.

Basic Qualifications:

• High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience
• Bachelor’s Degree OR
• AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR

Preferred Qualifications:

• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Identifying, writing, evaluating, and closing OOS’s and investigations.
• Ability to communicate and work independently with scientific/technical personnel.
• Deep knowledge of GMP, SOPs and quality control processes.
• Preferred: Experience in the biotech and/or pharmaceutical industry.
• Proficient in MS Word, Excel, Power Point and other applications.
• Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• Deep written and verbal communication skills.

Does this sound like you? If so, apply today!

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The salary range for this position is: $65,960.00 - $85,360.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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