Senior Specialist, QC Investigations Job at EPM Scientific, Burlington, VT

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  • EPM Scientific
  • Burlington, VT

Job Description

Title: QC Investigations, Senior Specialist

Location: Burlington, VT

Position Overview:

A regulated manufacturing site is seeking a Senior Quality Control professional to lead laboratory investigations and support continuous improvement within the quality system. This role is responsible for identifying root causes of lab-related issues, proposing corrective actions, and ensuring compliance with industry standards. The position requires strong analytical skills, cross-functional collaboration, and the ability to communicate findings effectively to leadership.

Key Responsibilities:

  • Lead investigations into laboratory incidents, data trends, and unexpected results.
  • Develop and document CAPAs and formal investigation reports.
  • Collaborate with QC and cross-functional teams to resolve quality issues.
  • Analyze data and present findings to site and corporate leadership.
  • Author and revise SOPs, specifications, and change control documentation.
  • Support regulatory submissions and documentation for post-approval changes.
  • Conduct training on investigation procedures, GMP compliance, and lab systems.
  • Participate in project teams and continuous improvement initiatives.
  • Perform trending assessments to identify and address recurring issues.

Qualifications:

  • Bachelor's degree with 4+ years of experience in QC and GMP environments (or equivalent).
  • Strong understanding of pharmaceutical quality systems, analytical chemistry, and GMP standards.
  • Experience with investigation documentation and CAPA development.
  • Effective communication and data analysis skills; ability to work across teams.

If this sounds of interest, please apply directly in for more information!

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