Quality Assurance Specialist III
Company: GForce Life Sciences
Posted on: August 2, 2022
QA Specialist III SummaryOur Client is seeking a highly
motivated individual to join us as a QA Specialist III, Quality
Assurance, Compliance. In this role you will be responsible for a
variety of Quality activities to ensure compliance with applicable
quality objectives and regulatory requirements. This individual
will be located at our Oceanside, CA site and report to Director of
Quality Assurance. This is a Contract To Hire role.Duties /
Expectations of Role
- Leading or supporting compliance, data integrity, policies and
practices to ensure compliance with regulatory requirements and the
Client's procedures and Corporate Policies.
- Conducting Gap Analysis for various systems.
- Leading Internal Audits, preparing audit reports and reviewing/
evaluation audit responses. Supporting responses to Corporate
- Be able to review quality control, validation and other records
for regulatory compliance and site procedures.
- Reviewing and approving Quality Control data, protocols/
reports, test methods, specifications and other documentation
related to QC department.
- Reviewing test results (in-house and by Contract Laboratory)
for product release and Stability Study; ensuring that QC
deviations / discrepancies, change controls and other applicable
records are resolved/closed prior to batch release.
- Supporting, reviewing and approving (as applicable) records /
activities related to Quality Control, such as Laboratory
Investigations, Out-of-Specifications, deviations,
- Proposing corrective/ preventive actions for discrepancies
related to QC. Capability to implement such improvements with
- Supporting test methods validations conducted by QC.
- Reviewing test results and annual reports for Environmental
Monitoring (EM) program.
- Provide information for Product Quality Reviews and participate
in review/approval of PQRs.
- When requested, write, revise and review SOPs, manufacturing
documents, methods, specifications, protocols and reports.
- Supporting Management during regulatory agency inspections, the
Client's Global and other audits. Mandatory Requirements
- 5+ years of experience with BS degree in the biological
sciences or related field.
- Working knowledge of electronic systems is a plus.
- Working knowledge and ability to apply GMPs in conformance to
U.S. and EU standards.
- Ability to effectively negotiate and build collaboration
- Proficient in MS Word, Excel, Power Point and other
applications. Familiarity with electronic systems for Batch Record,
Quality Management Systems, Agile (Oracle EBS), SAP, Veeva and
Smartsheet is a plus.
Keywords: GForce Life Sciences, Oceanside , Quality Assurance Specialist III, Other , Oceanside, California
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