Quality Assurance Specialist II
$65,000–$80,000 year
On-siteUnion, New Jersey, United States
EXPIREDUnion, New Jersey, United StatesOn-siteFull Time$65,000–$80,000 yearBachelors DegreeElectrical And Electronic ManufacturingEnterprise
Full TimeBachelors DegreeEnterpriseElectrical And Electronic Manufacturing
Job Summary
Conduct routine oversight of ongoing clinical studies by performing real-time reviews of documentation and timely escalations of events or non-compliances. Perform audits of internal processes according to ISO 19011 standards and support regulatory audits while ensuring adherence to the Quality Manual at the Union site. Monitor key performance indicators to ensure study completion timelines are met through collaboration with cross-functional teams. Create cross-training course lists to ensure qualified backup QA support across North America.
Required Qualifications
- Bachelor's degree in one or more of the following areas: Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, Regulatory Compliance, etc.
- 3+ years of experience as a Quality Assurance Processional
- 2+ years of experience in a Quality Assurance or Operational Leadership role
- Working knowledge of GCP, GDP, GLP and ICH E6 standards Required
- 1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team Required
- 2 year of experience in clinical monitoring
- Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniques
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