Quality Systems Specialist II

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Oct 04, 2019
Ref
R0009744
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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!

We are seeking a highly motivated individual to join as a Quality Systems Specialist II reporting to the Quality Systems and Compliance Manager. The Quality Systems Specialist will provide oversight of Kite's quality systems (Deviations and Laboratory Investigation). This position will be located at Kite's Commercial manufacturing site in El Segundo, CA.

Responsibilities (include but are not limited to):

Establish and maintain a deviation and Laboratory Investigation management system compliant with regulatory, quality, and Kite requirements.

Provides guidance and advice on methods, procedures, standardization and requirements associated with the deviation and LIR systems.

Responsible for system triage meeting facilitation.

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 and corrective actions implemented.

Develops, implements and delivers training content for deviation and laboratory investigations processes and procedures.

Responsible for procedure reviews and facilitating procedure updates for the deviation and LIR systems.

Assure that personnel are adequately trained in the principals, policies, and procedures of the deviation and laboratory investigations 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.

Skills/Qualifications

BS/BA with minimum of 5 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems. MS/MA degree with a minimum of 3 years of experience.

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 and LIR systems 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

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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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