Microbiology Labortory Coordinator
Flexible & Integrated Technical Services
- Añasco, PR
- Permanente
- Tiempo completo
- Bachelor’s degree in Natural Science (Biology or Microbiology preferred) and previous exposure to Laboratory activities within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills (English and Spanish)
- Shift: Administrative & according to business needs.
- Experience in:
- Laboratory (micro)
- Investigations
- GMP & GDP regulations
- Executes and/or verifies the required testing required for the product release, environmental program, validation and extraordinary facilities events.
- Coordinates, distributes and monitors the different tasks assigned to the Laboratory Technicians
- Provides technical support to Laboratory Technicians when problems arise with methods or instruments of the area.
- Actively participates in the laboratory investigation process. Assists on internal and/or external audits, complaints and product impact analysis
- Resolves situations presented on a day-to-day basis to ensure compliance with the work itinerary.
- Recommends and requires appropriate corrective actions in response to results above the established levels.
- Reviews the operational procedures related to the area; local procedures, methods, specifications, etc., to comply with regulations, policies, and / or internal procedures.
- Coordinates (external service personnel) and/or executes the qualification of the area equipment, as required by the procedure, necessary to perform the tests.
- Ensures that laboratory instruments are found in and operate in good condition, that preventive maintenance and calibrations are scheduled for each instrument.
- Generates orders for maintenance of equipment.
- Prepares monthly metrics, and trend analysis related to the laboratory performance.
- Attend to required meetings related to the laboratory performance
- Provides trainings and awareness to the Laboratory Technicians as required.
- Submits purchase requisitions and maintains laboratory inventory at an adequate level, and initiates requisitions for replenishments in a timely manner.
- Manage projects as required.
- Escalates compliance events and is member of the resolution team.