Quality Control Specialist III

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible, together.

Job Description

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!

Kite is seeking a highly motivated individual to join Kite as a QC Specialist III, Global Quality Control, to provide Quality Control support of Global Raw Materials and Reagents Center of Excellence (GRM&R CoE). In this role you will be responsible for the testing, release, and characterization of raw material and reagents, within a Good Manufacturing Practices (GMP) environment.

Responsibilities:

• Independently performs routine Raw Materials release testing by following established procedures as written.
• Participates as needed in the testing of raw materials by following analytical methods compendial methods and/or analytical procedures such as, pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel/Western Blot, FT-IR, HPLC, LC-MS, PCR, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays, and other applicable methods for the testing of Raw Materials and Reagents.
• Responsible for equipment lifecycle, maintenance, and calibration, is performed in a timely manner, as assigned.
• Responsible for the investigation and evaluation of non-conformances related to laboratory testing, laboratory OOS investigations, deviations, CAPAs and change controls, as assigned.
• Responsible for QC Testing Training program, as assigned.
• Supports Audits.
• Provides data analysis and trending.
• Provides technical solutions to a wide range of difficult problems.
• Leads/coordinates Quality Control and cross-functional projects with limited direction.
• Training and cross-training of junior employees,
• Drive department goals/objectives.
• Authors and revises Standard Operating Procedures.
• Compile data for trending or investigation purposes or conduct research in regulatory guidance and peer-reviewed journals.
• Performs GMP documentation with attention to detail.
• Gathering of documentation and data entry.
• Documentation and test record review.
• Keeps laboratory area clean and ensures waste is properly disposed.
• Keeps laboratory reagent and supply inventory.
• Supports the department with other duties as assigned.

Basic Qualifications:

• Master’s Degree and 3 years’ experience in the biotech/biopharmaceutical setting OR
• Bachelor’s Degree and 5 years’ experience in the biotech/biopharmaceutical setting OR
• Associate and 7 years' experience in the biotech/biopharmaceutical setting OR
• High School Diploma/GED and 9 years' experience in the biotech/biopharmaceutical setting

Preferred Qualifications:

• Thorough understanding and experience operating within an GMP environment.
• Working knowledge and understanding of analytical techniques to include HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents within an GMP environment.
• Experience leading OOS’s, CAPAs, change controls, deviations, and laboratory investigations.
• Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry.
• Preferred, Knowledge of aseptic technique and previous experience with cell culture.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects.
• Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.
• Ability to independently perform duties and be adaptable to a dynamic and fast-paced environment.
• Excellent interpersonal and organizational skills.
• Strong project and time management skills.
• Excellent oral and written communication skills.
• Proficiency in MS Word, Excel, Power Point and other applications.
• Experience using laboratory and quality systems (e.g., Empower).

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

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The salary range for this position is: $104,805.00 - $135,630.00. 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 ApplicantAccommodations@gilead.com for assistance.

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

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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.

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