Quality Assurance Specialist
Aviso de fuente externaen Infotree Global Solutions
Support the Client Quality Assurance program through quality reviews, approvals, investigations, audits, and lot disposition.
Salario
No especificado
Ubicación
Juncos, Puerto Rico
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Quality Assurance Specialist
Juncos, Puerto Rico
Descripción del empleo
About the role
Support the Client Quality Assurance program under minimal supervision.
Responsibilities
- Review and approve product MPs, work orders, EMS/BMS alarms, risk assessments, and change controls.
- Approve process validation protocols and reports, Environmental Characterization reports, planned incidents, NC investigations, and CAPA records.
- Request Quality on the incident triage team and represent QA on the NPI team.
- Release sanitary utility systems and provide lot disposition and shipment authorization.
- Lead investigations and site audits; own site quality program procedures.
- Serve as designee for the QA manager on local CCRB.
- Support automation activities, facilities, and environmental programs.
Requirements
- Doctorate, or a master's degree and 2 years of directly related experience, or a bachelor's degree and 4 years of directly related experience, or an associate's degree and 8 years of directly related experience, or high school/GED and 10 years of directly related experience.
- Project management, organizational, cross-functional leadership, influencing, and negotiating skills.
- Strong knowledge in the area of expertise and of processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Ability to collaborate with higher-level outside resources and interact with regulatory agencies.
- Strong word processing, presentation, database, spreadsheet, communication, facilitation, and presentation skills.
- Ability to work independently, interact with various levels, and perform advanced data trending and evaluation.
Datos clave
- The role supports the Client Quality Assurance program under minimal supervision.
- Qualifications include a doctorate or an alternative education and directly related experience combination.
- Responsibilities include leading investigations and site audits.
Preguntas frecuentes
What does the role involve?
It supports the Client Quality Assurance program. Responsibilities include quality reviews, investigations, audits, and lot disposition.
What education and experience are required?
The listing accepts a doctorate, or a master's degree with 2 years of directly related experience, a bachelor's degree with 4 years, an associate's degree with 8 years, or high school/GED with 10 years.
What skills are listed?
The role calls for project management, organizational, communication, and presentation skills, along with strong knowledge of manufacturing and quality processes.