Quality Assurance Engineering Specialist

2 weeks ago


Phillipsburg, New Jersey, United States American Cybersystems Full time
Job Description

Innova Solutions is seeking a highly skilled Quality Assurance Engineering Specialist to join our team. As a Quality Assurance Engineering Specialist, you will be responsible for supporting the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with Client policies, standards, procedures, and Global cGMP.

Key Responsibilities:
  • Facilitate Change Control Review Board (CCRB) and record tracking meetings as applicable.
  • Drive proactive and corrective improvements within Operations.
  • Provide support at all regulatory inspections and corporate audits.
  • Track internal/external audit commitments and drive on-time closure.
  • Evaluate new requirements and emerging regulations.
  • Provide user support for the different Quality Systems as a site lead, including integration activities and generation and review of Site Quality Metrics.
Requirements:
  • B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry.
  • Experience with cGMP manufacturing, Quality, and compliance.
  • Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
About Innova Solutions:

Innova Solutions is a global technology and business transformation solutions provider. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields.



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