Quality Control Specialist I – Sample Management

Quality Control Specialist I – Sample Management

14 Aug 2024
Maryland, Frederick, 21701 Frederick USA

Quality Control Specialist I – Sample Management

For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.Job DescriptionWe are seeking a highly motivated individual to join us as a QC Specialist I for the Quality Control Lab Support group at the Kite TCF05 Facility in Frederick, MD.In this role, you will follow through tasks associated with Sample Management, Raw Material Release, Shipping, System Administration, Deviation Investigations, other Lab Support QC functions, and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing, Material Management (MM)and Corporate teams.This role will be Wed - Sat 3pm – 2am Responsibilities (include but are not limited to):

Serve as SME on assigned QC Lab Support processes including LIMS.

Follow through processesto support sample receipt and processing for In-Process, Final Product, Retain, Back-up, and Stability samples.

Work with MM, QA and other QC functions to implement and support requirements around Raw Material sampling, testing and disposition.

Develop and complete all shipping activities within all QC functions.

Perform System Administration functions for QC Equipment.

Complete routine record review of records, e.g., of sample chain of custody, processing, logbooks, and other documentation generated within QC Lab Support.

Conduct training on assigned QC processes.

Author controlled documents such as SOPs, forms, etc., as needed.

Author deviations, investigations, CAPAs and change controls as needed.

Complete desired training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements

Provide updates at daily and weekly meetings.

Participate in Lean Lab and other Operational Excellence initiatives in the group.

Additional duties as assigned.

Basic Qualifications:

Master’s Degree OR

Bachelor’s Degree and at least 2 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR

Associate Degree and at least 4 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR

High School Degree and at least 5 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory.

Preferred Qualifications:

Thorough knowledge in applying GMP in QC lab.

Exceptional attention to detail and ability to keep track of multiple ongoing projects

Proficient in Microsoft Office, Excel, Visio, and other related applications

Ability to effectively negotiate and develop collaboration within teams and amongst team members.

Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment

Comfortable in a fast-paces small company environment with minimal direction and able to adjust workload based on changing priorities.

Does this sound like you? If so, apply today!#LI-ML1#IND123The salary range for this position is: $78,455.00 - $101,530.00. Kite 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Kite Pharma Employees and Contractors:Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Change The World With UsEveryone 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.We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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