Quality Assurance Specialist II, Compliance
Company: GForce Life Sciences
Posted on: August 6, 2022
Quality Assurance Specialist II - Compliance SummaryOur Client
is seeking a highly motivated person for the role of QA Specialist
II- Compliance. This individual will be responsible for a variety
of Quality activities to ensure compliance with applicable quality
objectives and regulatory requirements and will be located at our
Oceanside, CA site and report to Senior Manager of Quality
Assurance. This is a Contract To Hire role.Duties / Expectations of
- Supporting compliance, data integrity, policies, and practices
to ensure compliance with regulatory requirements and the Client's
procedures and Corporate Policies.
- Conducting or supporting activities for Gap Analysis for
- Conducting or supporting Internal Audits and Corporate Audits,
preparing audit reports, and reviewing/evaluating audit
- Be able to review quality control, validation, and other
records for regulatory compliance and site procedures.
- Reviewing test results (in-house and by Contract Laboratory)
for product release and Stability Study.
- Supporting, reviewing, and approving (as applicable)
records/activities related to Quality Control, such as Laboratory
Investigations, Out-of-Specifications, deviations, and
- Reviewing test results and annual reports for Environmental
Monitoring (EM) and other trending reports, generated by QC.
- 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
- 3+ years of experience with a BS degree in the biological
sciences or related field.
- Working knowledge of electronic Quality Management Systems is a
- 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, PowerPoint, and other
- Familiarity with electronic systems for Batch Record, Quality
Management Systems, Agile (Oracle EBS), Veeva, and Smartsheet is a
Keywords: GForce Life Sciences, Oceanside , Quality Assurance Specialist II, Compliance, Other , Oceanside, California
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