Quality Systems Specialist III/QA Trainer
Company: Kite Pharma
Location: El Segundo
Posted on: January 16, 2022
Job DescriptionEveryone 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.We are seeking a
highly motivated individual to join as a Quality Systems III/QA
Trainer located at Kite's Commercial manufacturing site in El
Segundo, CA. Reporting into the Quality Systems and Compliance Sr.
Manager, you will provide oversight of Kite's quality systems
(Deviations, CAPA, EV, Change Control and
Training).Responsibilities (include but are not limited to):
- Establish and maintain a Deviation, CAPA, EV and Change Control
Management System compliant with regulatory, quality, and Kite
- Provides guidance and advice on methods, procedures,
standardization and requirements associated with these
- Collaborates with cross-functional departments to ensure timely
implementation of quality records.
- Support audits (internal, external) in order to verify that
regulatory and quality requirements have been met.
- Support Deviation system and ensure proper investigation and
root cause analysis are performed.
- Support CAPA/EV system to ensure proper corrective actions are
implemented and effective.
- Support Change Control system to ensure proper change and
impact assessments are performed and tasks are implemented.
- Develops, implements and delivers training content for
Deviation, CAPA, EV and Change Control processes and
- Responsible for procedure reviews and facilitating procedure
updates for the Deviation, CAPA, EV and Change Control
- Assure that personnel are adequately trained in the principals,
policies, and procedures of the Deviation, CAPA, EV and Change
- Support tracking and communication of site metrics to
- Identify and escalate compliance gaps across quality
- Manages GMP onboarding at the site.
- Deliver Train the Trainer (OJT) program to the site
- Performs administration and maintenance of the Learning
Management System (LMS)
- Deliver / design high quality training and effectively support
- Works with SMEs in developing On the Job Training and in
managing the Training Effectiveness program.
- Organizes and conducts training programs for personnel through
formal classroom courses, one-on-one sessions and workshops.
- Designs and/or conducts site training program to meet
compliance goals, meet development needs, and support site
- Serves as subject matter expert on best practices and training
delivery methodologies, curriculum development for the site.
- Interacts with functional organizations to develop training
- Evaluates the effectiveness of trainings, implementing
modifications, when necessary, and monitoring training compliance
- Perform other duties as required.Basic Qualifications:
- Master's Degree and 3+ years' experience in a GMP environment
related field OR
- Bachelor's Degree and 5+ years' experience in a GMP environment
related field OR
- High School Degree and 9+ years' experience in a GMP
environment related fieldPreferred Qualifications:
- Strong knowledge of GMP, SOPs and quality system
- Excellent organizational skills and ability to review and
update processes or procedures.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and
electronic quality management systems.
- Strong written and verbal communication skills.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Education or training in cell culture and gene therapy
manufacturing environment a plus.
- Proficient in drafting and completing technical documents and
- Expertise in document management processes.
- Works on multiple assignments in collaboration with various
department system owners.
- Quality systems demonstrated knowledge in areas such as
Deviation, CAPA, EV and Change Control system management
- Working knowledge of quality systems and regulatory
requirements (21 CRF Part 11/210/211).
- Comfortable in a fast-paced environment with minimal direction
and able to adjust workload based upon changing priorities.
- Demonstrates basic understanding of training, instructional
design, communication and/or education.
- Demonstrates knowledge and understanding of pharmaceutical
manufacturing and quality assurance, aseptic and packaging
processes and product transfer.
- Demonstrates functional and process knowledge to support the
integrated design and development of training programs.
- Demonstrates ability to administer electronic Learning
Management Systems (LMS).
- Demonstrates presentation skills with the ability to conduct
- Proven organizational skills, planning skills and ability to
work effectively within teams.
- Demonstrates ability to lead cross-functional project
teams.Does this sound like you? If so, apply today!#IND123
Keywords: Kite Pharma, Los Angeles , Quality Systems Specialist III/QA Trainer, Human Resources , El Segundo, California
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