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Gilead Sciences, Inc. Quality Systems Specialist I - $8,000* Sign On in El Segundo, California

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

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.

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.

We are seeking a highly motivated individual to join as a Quality Systems I located at Kite’s Commercial manufacturing site in El Segundo, CA. Reporting into the Quality Systems and Compliance Sr. Manager, you will provide oversight of Kite’s quality systems (Deviations, CAPA, EV, Change Control and Training).

Responsibilities:

  • Establish and maintain a Deviation, CAPA, EV and Change Control Management System compliant with regulatory, quality, and Kite requirements.

  • Provides guidance and advice on methods, procedures, standardization and requirements associated with these systems.

  • Collaborates with cross-functional departments to ensure timely implementation of quality records.

  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.

  • Support Deviation system and ensure proper investigation and root cause analysis are performed.

  • Support CAPA/EV system to ensure proper corrective actions are implemented and effective.

  • Support Change Control system to ensure proper change and impact assessments are performed and tasks are implemented.

  • Develops, implements and delivers training content for Deviation, CAPA, EV and Change Control processes and procedures.

  • Responsible for procedure reviews and facilitating procedure updates for the Deviation, CAPA, EV and Change Control systems.

  • Assure that personnel are adequately trained in the principals, policies, and procedures of the Deviation, CAPA, EV and Change Control systems.

  • Support tracking and communication of site metrics to management.

  • Identify and escalate compliance gaps across quality systems.

  • The standard work week for this position is Monday through Friday with occasional weekend work.

Basic Qualifications:

  • Master’s Degree OR

  • Bachelor’s Degree and 2+ years’ experience in a GMP environment OR

  • AA Degree and 4+ years’ experience in a GMP environment OR

  • High School Degree and 5+ years’ experience in a GMP environment

Preferred Qualifications:

  • Strong knowledge of GMP, SOPs and quality system processes.

  • Excellent organizational skills and ability to review and update processes or procedures.

  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.

  • Strong written and verbal communication skills.

  • Experience in pharmaceutical or bio-pharmaceutical field.

  • Education or training in cell culture and gene therapy manufacturing environment a plus.

  • Proficient in drafting and completing technical documents and presentations.

  • Expertise in document management processes.

  • Works on multiple assignments in collaboration with various department system owners.

  • Quality systems demonstrated knowledge in areas such as Deviation, CAPA, EV and Change Control system management practices/strategies.

  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

  • Demonstrates basic understanding of training, instructional design, communication and/or education.

  • Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes and product transfer.

  • Demonstrates functional and process knowledge to support the integrated design and development of training programs.

  • Demonstrates ability to administer electronic Learning Management Systems (LMS).

  • Demonstrates presentation skills with the ability to conduct training sessions.

  • Proven organizational skills, planning skills and ability to work effectively within teams.

  • Demonstrates ability to lead cross-functional project teams.

*This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.

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 .

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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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

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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.

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.

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