Position Title: Quality Assurance Specialist Work Location: Thousand Oaks, CA 91320 Assignment Duration: 12 Months Work Arrangement: Onsite
Position Summary: This position supports our organization's Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
Key Responsibilities:
Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures.
Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues.
Executes quality oversight directly in our organization's Quality systems.
Qualifications & Experience:
Bachelor’s degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices.
Experience managing projects through completion while meeting timelines.
Evaluating documentation and operations according to company procedures and related regulations.
Experience working with Quality Systems.
Strong organizational skills and ability to manage multiple tasks at one time.
Effective communication skills (both written and verbal).
Demonstrated ability to work as both a team player and independently.
Solid understanding and application of aseptic behaviors and principles.
Commissioning, Qualification, and Validation experience.
Experience with direct use of GMP quality systems (i.e. Deviation and Change Management, Equipment Maintenance and Lifecycle Management, Controlled Document Management systems).
Direct experience working or supporting GMP manufacturing, Facility and Engineering, or Quality Assurance teams within the biotech industry.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 40.00/hr.
