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!
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