Quality Engineer - III
Company: Calsoft Labs
Location: Santa Monica
Posted on: June 13, 2022
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Job Description:
Job Description
Quality Engineer III
Job Description
Kite is a cell therapy company that is focused on providing
patients with highly effective, life-saving therapies. 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 to join us as Quality
Engineer III, at our location in Santa Monica. The ideal candidate
will interface and build strong partnerships with other parts of
the organization. This position must excel in an environment that
embraces teamwork, change, risk-based decision making, and
flexibility.
The candidate will be responsible for overseeing and approving
laboratory equipment validation strategies required to complete
assigned validation projects. An ideal candidate would have
extensive experience with the performance of such validation
activities that include Equipment/Utility/Facility Qualification
and Cleaning Validation across the entire validation lifecycle from
Plan to Retire.
This role is expected to make a significant contribution to a
multi-disciplinary team driving adherence and consistent
implementation of the Pharmaceutical Quality System across the
network. A successful individual will be self-motivated to take
actions and have excellent written, verbal communication, and
critical thinking skills.
Responsibilities:
Lead and/or support risk analysis activities. Demonstrate
proficiency in applying various risk management and risk mitigation
tools and practices such as FMEA and others.
Create and maintain the site validation master plan and its
periodic review program.
Lead/coordinate completion of Equipment Qualification deliverables
such as user requirement specifications (URS), system impact
assessments (SIA), Qualification Protocols (IQ/OQ/PQ), Design
Specifications, Functional Risk Assessments (FRS), etc.
Ensure periodic reviews of Risk Management Reports are performed
according to schedule.
Support change controls and related activities
Ensure validation and data integrity requirements are met in
accordance with company procedures
Provide insight as a subject matter expert (SME) on the risks
associated with analytical equipment such as chromatography,
compendial analytical methods, Flow Cytometry, etc.
Provide insight as a subject matter expert (SME) on the risks
associated with data integrity associated with analytical
equipment.
Provide quality oversight of site Validation Engineering execution
activities, and external partners
Apply Statistical methods and Data Analytical Tool for Data
Analysis.
Support Equipment and laboratory life cycle processes.
Support continuous improvement initiatives and identify and
implement tools/processes for continuous improvement
Communicate effectively at all levels within Quality, as well as
cross functionally with departments and sites
Perform other duties in support of the quality system as
assigned.
Basic Qualifications:
Masters Degree in technical discipline
(Engineering/Biology/Chemistry/Microbiology) and 3+ years
experience in a pharmaceutical or FDA regulated environment OR
Bachelors Degree in technical discipline
(Engineering/Biology/Chemistry/Microbiology) and 5+ years
experience in a pharmaceutical or FDA regulated environment OR
High School Degree in technical discipline
(Engineering/Biology/Chemistry/Microbiology) and 9+ years
experience in a pharmaceutical or FDA regulated environment
Preferred Qualifications:
Bachelors degree in Engineering with a strong knowledge of Quality
Engineering /Scientific Method and Techniques.
Excellent technical writing experience in a regulatory
environment.
Experience Equipment, Facility and Utility IQ/OQ/PQ/PV
Knowledge in computer System validation in a GMP environment
Strong Knowledge of Risk Assessments and Risk Mitigation tools
(e.g. FMEA).
Strong Knowledge of Change Control Practices
Strong written and verbal communication skills
Strong Analytical and Statistical skills
Familiarity with global regulatory agencies requirements for
Quality Risk Management and Quality
Systems (ICH Q9, GAMP5, 21CFR 11/210/211)
Ability to function efficiently in a diverse, fast paced, and
changing environment.
Keywords: Calsoft Labs, Santa Monica , Quality Engineer - III, Engineering , Santa Monica, California
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