Quality Assurance Compliance Investigator

2 weeks ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Title: Quality Assurance Compliance Investigator

Lynkx Staffing LLC is seeking a highly skilled Quality Assurance Compliance Investigator to join our team in Allendale, NJ. As a Quality Assurance Compliance Investigator, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities:
  • Conduct investigations and root cause analyses to identify and address quality and compliance issues.
  • Develop and implement corrective actions to prevent recurrence of quality and compliance issues.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company policies.
  • Review and approve investigations and corrective actions to ensure compliance with regulatory requirements and company policies.
  • Develop and maintain quality and compliance metrics to track performance and identify areas for improvement.
Requirements:
  • Bachelor's degree in a biological science or related field.
  • Minimum 5 years of experience in quality assurance in a life sciences company with a strong focus on manufacturing and/or testing of biologics.
  • Experience in authoring, reviewing, and approving cGMP/cGTP related documents.
  • Understanding of quality system applications, including electronic applications for training, deviations, and CAPA management.
  • Familiarity with FDA, ISO, and other regulatory agency guidelines.
  • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
Preferred Qualifications:
  • Experience in both clinical and commercial manufacturing.
  • Experience in supporting health authority inspections and/or client audits.
  • Relevant computer skills, including Microsoft Office and Outlook.

Lynkx Staffing LLC is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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