QA Investigations Lead
Juncos - Puerto Rico
Job Summary
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.
- 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.
- Bachelors 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).
Required Skills:
Bachelors 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).