United States flag

Senior Quality Assurance Specialist

United States - California - Santa MonicaQualityRegular

Job Description

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 who is a team player and has a mindset of growth, contribution and continuous improvement to join us as a Senior Quality Assurance Specialist. 

The Senior 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 practices. In addition, you will also provide objective evaluation of process performance and product quality, and support the department for continual contributions towards site and Kite’s quality goals. This role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of Kite Pharma.

Responsibilities (include but are not limited to):

  • Work closely with and provide quality oversight across functions (Manufacturing, Supply Chain, Site QC, Process Development, Regulatory Affairs, Site QA and) within Kite and externally to assure compliance and strong relationships.
  • Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to:
  • Batch documentation review and ensure resolution of issues to release product
  • Review and approval of product-related Deviations and CAPAs
  • Disposition of product for U.S. and other countries
  • Support of New Product Introductions
  • Support quality assessments of internal operations to analyze quality compliance and assess risk
  • Provide QA guidance on product development projects and technical transfer activities
  • Support Management Review activities and oversee trending of key quality, product and GMP metrics
  • Review and approve non-product related Deviation investigations and CAPAs, and ensure timely closure and effectiveness of investigations and corrective and preventive actions
  • May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions
  • Support regulatory inspections, internal audits, and external audits from partners
  • Review technical (process and analytical) reports as appropriate
  • Support the viral vector manufacturing site
  • Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned
  • Support Quality on the floor process
  • Support Management Review activities and oversee trending of key quality, product and GMP metrics
  • Up to 10% domestic travel
  • Perform other duties as assigned

 

Basic Qualifications:

  • Master's Degree and 4+ years of experience in a GMP environment in the biological sciences or related field OR
  • Bachelor's Degree and 6+ years of experience in a GMP environment in the biological sciences or related field OR
  • High School Degree and 10+ years of experience in a GMP environment in the biological sciences or related field

Preferred Qualifications:

  • In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
  • Proficient in cGMP regulations, quality systems and regulatory requirements.
  • Experience writing, evaluating and closing investigations, CAPAs and change control records.
  • Experience with conducting and managing internal and external audits.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
  • In-depth understanding and application of qualification and validation principles, concepts, practices, and standards.
  • Ability to effectively negotiate and build collaboration amongst individuals.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Willingness to think outside of the box and adapt best practices
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.