Senior Specialist, QC Investigations

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!