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Laboratory Investigations Scientist-Parenteral
Job Location:
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
3years
Experience Required:
Posted:
6 June 2026 (30+ days ago)
Posted:
Application Deadline:
3 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
The Laboratory Investigations Scientist is responsible for conducting documenting and supporting investigations related to deviations out-of-specification (OOS) results and non-conformances associated with the testing and manufacturing of parenteral (sterile injectable) products. This role ensures compliance with cGMP regulations while supporting root cause analysis and implementing corrective and preventive actions (CAPA).
Key Responsibilities:
- Lead and support laboratory investigations for OOS OOT (Out of Trend) deviations and atypical results related to parenteral products.
- Perform root cause analysis using structured methodologies (e.g. fishbone diagrams 5 Whys).
- Review analytical data laboratory documentation and manufacturing records to identify discrepancies.
- Collaborate with Quality Assurance Manufacturing Microbiology and Analytical teams to support investigations.
- Ensure investigations are completed in a timely manner and in compliance with cGMP FDA and regulatory requirements.
- Prepare detailed investigation reports including conclusions and recommended CAPAs.
- Support implementation and effectiveness checks of CAPAs.
- Participate in audit readiness activities and support inspections as needed.
- Identify opportunities for continuous improvement in laboratory processes and investigation practices.
- Maintain proper documentation practices in compliance with data integrity requirements (ALCOA principles).
Requirements
Required Skills:
Bachelor Sciences
Required Education:
Bachelor Sciences
