- Title: Quality Specialist II
- Code: RCI-11019
- Location: Santa Monica, CA 90404
- Posted Date: 01/14/2022
- Duration: 12 Months
Talk to our Recruiter
- Name:Rohit Sughani
- Email: email@example.com
- Phone: 908-704-8843 ✖ 293
Onsite: 2 days/wk onsite
Vaccination Policy in effect due to the onsite nature of the role
- 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.
- 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.