Sr. Quality Assurance Specialist

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 07, 2019
Ref
R0009793
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 us as a Sr. Quality Assurance Specialist. This role will report into the Quality & Compliance R&D Director and you will perform a wide variety of activities to ensure compliance with applicable regulatory requirements and Good Clinical Practice (GCP).

Key Responsibilities (include but are not limited to):

Participate in developing Standard Operating Procedures to ensure quality across internal processes

Create modify and implement clinical trial risk assessment plan.

Keep abreast regulatory developments within or outside the company as well as evolving best practice in compliance control

Support compliance audits as necessary.

Interface with stakeholders to address documentation and compliance issues.

Facilitate and support inspection readiness activities

Develop and provide independent periodic reports to management on overall compliance status

Provide updates at daily and weekly meetings

Minimum 25% travel

Other duties as assigned

Skills/Qualifications:

7+ years of relevant experience in Good Clinical Practice (GCP) environment and a Bachelor's degree in science or related fields or 5+ years of GCP experience and a MS.

Knowledge and experience in quality assurance in a highly regulated environment.

Previous experience of working in a global company

Experience in clinical trials with biologics with cellular therapies a plus

Proficient in MS Word, Excel, Power Point and other applications

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

In-depth knowledge of GxP, QA principles, concepts, industry practices, and standards.

Keen understanding of Computer Systems Validation and ICH Guidelines.

Excellent verbal, written and interpersonal communication skills.

Working knowledge of Risk Management tools

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.

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