QA Investigations Lead
QRC Group, LLC•Gurabo, PR
About The Position
QA Investigations Lead – to oversee and drive the end-to-end investigation processes within a regulated environment. This role will ensure timely, compliant, and effective resolution of quality events while providing strong project management oversight. The selected candidate will be responsible for managing investigation workflows, tracking key metrics, leading cross-functional meetings, and challenging teams to ensure thorough root cause analysis and sustainable corrective actions.
Requirements
- Bachelor’s Degree in Sciences
- 10+ years of QA experience in the pharmaceutical industry.
- Strong knowledge of cGMP and quality systems.
- Proficiency in TrackWise, SAP, MS Office.
- Excellent communication skills in English and Spanish (speak, understand and write).
Responsibilities
- Lead and manage the Quality Investigation System.
- Supervise and develop Data Reviewers team.
- Conduct daily triage meetings and weekly investigation status reviews.
- Ensure timely assignment, execution, and closure of investigations.
- Prepare and present monthly quality metrics to site.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
