QA Engineer
Flexible & Integrated Technical Services, LLC
- Añasco, PR
- Permanente
- Tiempo completo
- Bachelor’s degree in Natural Science (Chemical or Biology preferred) or Engineering and a minimum of ten (10) years of exposure in Quality activities within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills (English and Spanish)
- Shift: Administrative & according to business needs
- Experience in:
- Validation Life Cycle
- Change Control
- Documentation
- GMP & GDP regulations
- Support the implementation of effective quality engineering processes for new products, processes, and technology.
- Provides support to the validation and certification of process, test methods, equipment, software, utilities and facilities as required.
- Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
- Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
- Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
- Works with multi-functional teams to establish project plans and ensures uninterrupted support to new projects balanced with manufacturing operations.
- Develops standard operating procedures, specifications, and provides technical transfer and validation support.
- Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.