What are the responsibilities and job description for the QA Investigations Specialist position at Insight Global?
We are seeking a Quality Assurance professional to support an established QA Investigations team. This role will act as the quality authority for deviation and investigation review, ensuring investigations are thorough, compliant, and aligned with GMP expectations. The ideal candidate brings hands on experience in either biotech manufacturing or Quality Control, followed by experience reviewing investigations from a QA perspective. Candidates without manufacturing or QC experience must demonstrate extended experience functioning as a quality authority reviewing investigations.
Key Responsibilities
- Review and approve deviation investigations, root cause analyses, and corrective and preventive actions
- Act as the quality authority to ensure investigations meet GMP and regulatory requirements
- Assess investigation quality, completeness, and scientific rationale
- Partner with Manufacturing, Quality Control, and other cross functional teams to drive timely investigation closure
- Provide guidance and feedback to investigation owners to improve investigation effectiveness and compliance
- Identify trends and recurring issues to support continuous improvement initiatives
- Support audits, inspections, and internal reviews related to investigations
Required Qualifications
- Bachelor’s degree in a scientific or technical discipline
- Several years of experience in biotech manufacturing or Quality Control, followed by experience reviewing investigations in a QA role
- OR extended experience serving as a quality authority reviewing investigations without prior manufacturing or QC background
- Strong understanding of GMP principles and regulated manufacturing environments
- Demonstrated experience reviewing and approving deviations and investigation documentation
- Ability to apply quality judgment and clearly articulate findings and decisions