Job Details

  • Title: Quality Specialist II
  • Code: RCI-11019
  • Location: Santa Monica, CA 90404
  • Posted Date: 01/14/2022
  • Duration: 12 Months
Talk to our Recruiter

  Job Description

Description:

 

Onsite: 2 days/wk onsite

Vaccination Policy in effect due to the onsite nature of the role

Required:

  • experience in Quality Systems management
  • experience with deviations, supplier complaints, CAPA, change control, root cause analysis, and performing investigations.

Responsibilities (include but are not limited to):

  • Owns product complaint records for Kite’s commercial and investigational products.
  • Interfaces with external customers and internal team members to facilitate resolution of complaint-related issues.
  • Own quality system records (e.g. deviations, CAPA) on behalf of the department.
  • Participates in the development, implementation, and maintenance to optimize department processes; writes and implements controlled documents, as needed.
  • Supports Supplier Quality Projects, including supplier classification and type categorization in quality management systems and decommissioning suppliers.
  • Performs Supplier Quality qualification requests Triage
  • Facilitates supplier change notifications to obtain impact assessment from cross functional departments.
  • Perform other duties as required to fulfill department and business needs.

Requirements:

  • 4+ years of relevant experience in a GMP environment related field and a BS or BA.
  • 2+ years of relevant experience and a MS.
  • Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience preferred.
  • Experience generating metrics preferred.
  • Demonstrates good technical writing, critical thinking, and problem-solving skills.
  • Demonstrates working knowledge of current GMPs, quality assurance systems, methods, and procedures.
  • Demonstrates knowledge of FDA, EMEA and ROW standards and quality systems.
  • Demonstrates basic knowledge of root cause analysis tools used for identifying and correcting deviations.
  • Previous experience supporting regulatory agency audits, preferred.
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.