Quality Systems Specialist III

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 11, 2019
Ref
R0008817
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join as a Quality Systems Specialist III located at Kite's Commercial manufacturing site in El Segundo, CA. Reporting into the Quality Systems and Compliance Manager, you will provide oversight of Kite's quality systems (Deviations, CAPA, EV, and Change Control).

Responsibilities (include but are not limited to):
  • 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.
  • Perform other duties as required.
  • The standard work week for this position is M-F with occasional weekend work required.


Qualifications:
  • 6+ years of relevant experience in a GMP environment related field and a BS.
  • 4 + years of relevant experience and a MS.
  • 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.
  • Ability to communicate and work independently with scientific/technical personnel.
  • 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.


IND123

#LI-ZN1

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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 to apply for this job.