Quality Assurance Specialist I
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Job Description
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we’re not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system’s procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.
*** Wed-Sat 0700 – 1730***
Responsibilities (included but not limited to):
- Provide QA support on the floor for production
- Ensure process control measures are in place and followed in product manufacturing
- Receipt and disposition of incoming apheresis material.
- Oversee and authorize shipment of final product
- Verify and ensure timely issuance of production documents and labels
- Review batch-related documentation and ensure resolution of issues to release and ship product.
- Gather and report metrics to measure performance
- Identify continuous improvement actions
- Ensure timely resolution and escalation of issues
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensure that associated CAPAs are initiated and resolved, as needed.
- Perform lot closure activities.
- Ensure approval and timely delivery of final product.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
- Perform other duties as assigned
Basic Qualifications:
- MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR
- BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience or experience in a GMP environment (Drug Substance or Drug Product) OR
- Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ years of Quality Assurance experience or experience in a GMP environment (Drug Substance or Drug Product) OR
- High School diploma and 5+ years of Quality Assurance experience or experience in a GMP environment (Drug Substance or Drug Product).
Preferred Qualifications:
- BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Strong teamwork and collaborative skills
- Experience with manufacturing investigations, deviations, and CAPA.
- General knowledge of aseptic manufacturing processes.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
- Willingness to think outside of the box and adapt best practices to a small, but growing environment
- Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Does this sound like you? If so, apply today!
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The salary range for this position is: $78,455.00 – $101,530.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 ApplicantAccommodations@gilead.com for assistance.