QA Specialist - I
Company: Intelliswift Software Inc
Location: Santa Monica
Posted on: March 12, 2023
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Job Description:
Quality Assurance Specialist I
The Quality Assurance Specialist I 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.
Responsibilities (include but are not limited to):
--- Disposition raw materials globally for Kite manufacturing
network
--- Review material related documentation and ensure resolution of
issues to release material
--- Manage Kite Pharma Quality Systems for Global Raw Materials and
Reagents group
--- Provide quality oversight for the QC lab for raw material
testing
--- Execute Quality walk through for QC Lab for raw material
testing
--- Review batch-related documentation and ensure resolution of
issues to release product
--- Oversee material qualification process, approve material
qualification protocols, reports
--- Oversee material specification lifecycle process, approve
specification initiation, changes and obsolescence.
--- Manage Change Control system and ensure proper maintenance and
approval of cGMP documents.
--- Ensures change controls are initiated, evaluated and
implemented appropriately for all regulated changes.
--- Manage the Deviation and CAPA system and ensure timely closure
and effectiveness of investigations and corrective and preventive
actions.
--- Conduct effective root cause analysis and implement corrective
action and preventative action.
--- Host/support regulatory inspections, internal audits, and
external audits from partners.
--- Review technical/ investigation reports as appropriate.
--- Review and approve proposed changes to systems, and
procedures.
--- Provide QA guidance to material development projects and
technical transfer activities.
--- Provide data for Quality related metrics
--- Ensure all material-related Deviations and CAPAs are initiated,
investigated and resolved, as needed.
--- Participate in Material Review Board meetings to ensure
non-conforming material is appropriately dispositioned.
--- Up to 10% domestic travel
--- Perform duties as needed
Basic Qualifications:
--- Master's Degree and 5+ years' experience in cGMP regulations,
quality systems and regulatory
requirements OR
--- Bachelor's Degree and 7+ years' experience in cGMP regulations,
quality systems and regulatory
requirements OR
--- High School Degree and 11+ years' experience in cGMP
regulations, quality systems and regulatory requirements
Preferred Qualifications:
--- Degree in the biological sciences or related field
--- Direct management/leadership experience in a pharmaceutical or
biologics operation.
--- Experience in identifying, writing, evaluating and closing
CAPAs.
--- Experience with conducting and managing internal and external
audits.
--- Strong knowledge of change control practices/strategies.
--- Proficient in MS Word, Excel, Power Point and other
applications.
--- Ability to effectively negotiate and build collaboration
amongst individuals.
--- Demonstrated ability to develop, coach, and mentor key
employees
--- Excellent interpersonal, verbal and written communication
skills are essential in this collaborative work environment.
--- Preferred: ASQ, Black Belt/Green Belt certifications.
--- Comfortable in a fast-paced small company environment with
minimal direction and able to adjust workload based upon changing
priorities.
Keywords: Intelliswift Software Inc, Santa Monica , QA Specialist - I, Other , Santa Monica, California
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