Laboratory Technician
- Caguas, PR
- Permanente
- Tiempo completo
- Primary Functions:
- Receives and logs samples, reviews analytical data, prepares certificates of analysis.
- Performs non-conventional testing (e.g., force degradation, method validation, in process samples, bioequivalence dissolution).
- Perform Tests API, raw materials, in-process samples , research samples, and finished products following specifications.
- Revises SOPs and completes daily schedule.
- Manages lab inventory and generates purchase requisitions.
- Maintains files and records.
- Attends development meetings.
- Supports EHS program.
- Performs laboratory housekeeping.
- Documents testing activities in logbooks and notebooks.
- Performs other assigned duties.
- Writes/assists in laboratory protocols deviation reports.
- Handles controlled substances.
- Assists in data verification and reports discrepancies.
- Enters test results in the database and reports discrepancies.
- Secondary Functions:
- Assists in experimental work under limited supervision.
- Works with advanced instruments and performs troubleshooting.
- Keeps records and files up to date.
- Ensures proper handling of waste
- Minimum Requirements:
- Bachelor's Degree in Chemistry
- 2-4+ years of experience in a cGMP regulated analytical laboratory.
- Experience in method validation (execution of protocols and reports) and analytical technology transfer.
- Knowledge of FDA, ICH, GMP, and USP requirements for method validation and transfer.
- Computer literate.
- Excellent communication skills in English and Spanish.
- Other Requirements:
- Flexible to work flexible shifts including weekends.
- Works under pressure and adapts to dynamic changes in the working schedule.