QA Specialist III

Gilead Sciences Inc.; El Segundo (CA); On-site; USD 107,000 - 139,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

Kite Pharma, a biopharmaceutical company, seeks a QA/Compliance professional to uphold GMP/GLP, QA principles and regulatory standards across manufacturing, distribution and maintenance. The role emphasizes audit, investigation and strict documentation practices.

Based in Santa Monica, CA, the position offers potential bonus and stock incentives, with comprehensive benefits and opportunities to influence CAPA processes and regulatory readiness.

Qualifications

• GMP/GLP knowledge in regulated industry with auditing experience.
• Proficiency in QA principles, standards, and industry practices.
• Strong audit, investigation and report writing skills; familiarity with CAPAs.

Skills

GMP/GLP

QA principles

FDA/EMEA standards

Six Sigma/LEAN

Audit & investigations

MS Office

Education

Master’s Degree + 3+ years GMP

Bachelor’s Degree + 5+ years GMP

High School Diploma + 8+ years GMP

Job description

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 fulfill their aspirations. Join Kite and help create more tomorrows.

Job Description

Knowledge

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates strong verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in Microsoft Office applications.

Basic Requirements

• Master’s Degree with 3+ years of relevant GMP or regulated industry experience, including auditing experience;
• Bachelor’s Degree with 5+ years of relevant GMP or regulated industry experience, including auditing experience;
• High School Diploma with 8+ years of relevant GMP or regulated industry experience, including auditing experience.

Preferred Qualifications

• Provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and /or novelty.
• Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
• To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and /or novelty.
• Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation and CAPA processes at TCF03 in a compliant manner.
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

The salary range for this position is: $107,185.00 - $138,710.00. 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 .

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 [e-mail] for assistance.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.