QA Specialist
West Pharmaceutical Services
- Puerto Rico
- Permanente
- Tiempo completo
- Provide continuous and extensive assessment of all IR, Complaints, CAPA activities and documentation to ensure compliance with business practices, regulations, and ISO standards.
- Support the implementation of standardized procedures and systems for IRs, Complaints, and CAPA.
- Provide training for users in IRs, Complaints, and CAPAs to include investigation, root cause analysis, and review.
- Assist users with the development and documentation of problem statements, containment, implementation, correction, root cause, action plan, risk management and effective monitoring.
- Deliver metrics for IRs, Complaints, and CAPA to include weekly management tracking reports.
- Implement measures to monitor the effectiveness of the systems.
- Conduct review and approval of the IRs, Complaints, and CAPAs with attention to detail, review for completeness, accuracy, effectivity, and timeliness to include extension requests.
- Liaise with functional groups, facilitate and mentor teams through all stages of the processes.
- Ensuring users provide consistency to the IRs, Complaints, and CAPA system content. Follow IRs, Complaints, and CAPAs throughout the lifecycle of the content.
- As Subject Matter Expert, facilitate and coach IRs, Complaints, and CAPA teams in the application of problem-solving techniques and promote its use and development.
- Supports internal and external audits, inspections, batch history record review, calibrations, and record / document control.
- Performs other duties as assigned by the Quality Supervisor or Manager.
- Other duties as assigned.
- BS/BA degree preferably in a technical discipline (Business, Operations, Engineering, or Science).
- 0-3 years of experience
- List any required certifications.
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques. Strong analytical and decision-making skills.
- Experience in technical documentation, quality tools, and process improvement techniques.
- Influence management skills; ability to work constructively across all functions (internal and external customers).
- Excellent communications (including both written & oral methods), interpersonal, problem solving (including root cause failure analysis methods), planning/organizational, and negotiating.
- Computer skills required mainly with MS Office Applications, MasterControl, and other statistical analysis systems.
- Understanding of manufacturing and plant operations.
- Experience with GMPs, ISO 13485, and ISO 9000 standards.
- ASQ certification highly desired.
- Black Belt certification a plus.
- Chemistry or Engineering degree preferred.
- Graduate degree (MS) a plus.
- Minimal.
- Perform job duties as required with limited physical demands and some travel may be required.