QA Specialist - II

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy — a cell-based therapy which relies on chimeric antigen receptors and T cells.

About the role

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our El Segundo, CA site and report into the Sr. Manager of Quality Assurance Operations. The standard work week for this position is Monday–Friday, however weekend/night work will be required during manufacturing campaigns to support process operations.

Responsibilities

• Provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated, and resolved in accordance with established timelines.
• Provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures.
• Identify efficiencies in the execution of the Deviation and CAPA processes at TCF03 in a compliant manner.
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment, and material issues.
• Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Requirements

Basic Qualifications:

• Master’s Degree OR
• Bachelor’s Degree and 2+ years’ experience in the biological sciences or related field OR
• AA Degree and 4+ years’ experience in the biological sciences or related field OR
• High School Degree and 5+ years’ experience in the biological sciences or related field

Qualifications

Preferred Qualifications:

• Quality Control background in Analytical, Virological, and Microbiological testing
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, PowerPoint, and other applications
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Benefits

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan
• Legal Service Plans: Offering access to attorneys for legal advice and representation

Pay

$40.00/hr. to $44.24/hr. on W2

Work Authorization: USC or Green Card only