Quality Assurance Specialist Iii

3 days ago

Frederick, United States Kite Pharma Full time

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible, together.

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work.

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the impactfulness of a patient’s own immune system to selectively target cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team motivating to new frontiers of care for cancer patients.

We are seeking a highly motivated individual to join us as QA Specialist III at our commercial manufacturing site (currently under construction) in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations, Lot Disposition, Change Control and Exception Management / CAPA.

**_ ** Shift is Wed-Sat 1700-0330 **_**

**Responsibilities include (but are not limited to)**:

- Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
- Coordinate and facilitate Quality Assurance related production and production related activities, including:

- Assessment and closure of discrepancies, deviations and change controls requests.
- On-the-floor support Quality support to manufacturing and QC staff.
- Assessment and closure of laboratory investigations.
- Timely assessment and closure of batch and material hold events.
- Review of batch manufacturing and testing documentation for timely delivery of final product.
- Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
- Compile and verify all batch related documents into a final product lot disposition package.
- Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
- Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
- Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
- Provide periodic updates to stakeholders for deviations, GMP and system issues, non-conforming materials and products and CAPA.
- Perform other duties as required.

**Basic Qualifications**:

- Master’s Degree and 3+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
- Bachelor’s Degree and 5+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
- High School Degree and 9+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

**Preferred Qualifications**:

- Proficient in Quality Systems, particularly associated with Operations, Lot Disposition and Exception Management/CAPA.
- Thorough knowledge of GMP, SOPs and quality systems.
- Ability to effectively negotiate and develop collaboration amongst individuals.
- Excellent interpersonal, verbal and written communication skills.
- Experience with laboratory investigations, deviations, and CAPA.
- Experience with change control practices and strategies.
- General knowledge of aseptic manufacturin

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