Job Description
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
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Job DescriptionAt Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
As a Quality Assurance Specialist, your responsibilities will be, among others:
Performing a wide variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
Maintaining programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviewing manufacturing, environmental monitoring and quality control data for in process and finished products.
Contributing to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and Kite procedures.
Conducting or acts as a coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products and performs QA review and approval of deviations and CAPA.
Identifying and reports deviations from approved processes and procedures to senior colleagues
Participating in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
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About you
You have extensive experience in a GMP environment and hold a BSc degree or MSc degree.
You have working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
You demonstrate knowledge of FDA / EMA standards and quality systems.
Prior experience in pharmaceutical industry or similar bio industry is considered a strong plus.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates working knowledge of quality assurance systems, methods and procedures.
Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
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.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
