Sr. Specialist QA
Aviso de fuente externaen CIS International LLC
CIS International LLC seeks a Sr. Specialist QA in Juncos, Puerto Rico. Responsibilities include quality approvals, investigations, and site procedures.
Salario
No especificado
Ubicación
Juncos, Puerto Rico
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Sr. Specialist QA
Juncos, Puerto Rico
Descripción del empleo
About the role
CIS International LLC is seeking a Sr. Specialist QA in Juncos, Puerto Rico.
Responsibilities
- Approve process validation protocols and reports for manufacturing processes.
- Represent Quality on the incident triage team and QA on the NPI team.
- Approve Environmental Characterization reports and planned incidents.
- Release sanitary utility systems.
- Lead investigations and own site quality program procedures.
- Serve as designee for the QA manager on the local CCRB.
Requirements
- Education and directly related experience: doctorate plus 2 years; master's plus 4 years; bachelor's plus 6 years; associate's plus 10 years; or high school/GED plus 12 years.
- Project management, organizational, cross-functional leadership, influencing, and negotiating skills.
- Strong knowledge of 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, interact with regulatory agencies, work independently, and interact effectively with various levels.
- Strong communication, facilitation, presentation, word processing, database, and spreadsheet application skills.
- Advanced data trending and evaluation skills and ability to evaluate compliance issues.
- Demonstrate the Amgen Values/Leadership Practices.
Datos clave
- Full-time job.
- The source describes the job as full on site in Juncos, PR.
- Education and experience options range from doctorate plus 2 years to high school/GED plus 12 years of directly related experience.
Preguntas frecuentes
What are the main responsibilities?
The role approves validation protocols and reports, Environmental Characterization reports, and planned incidents. It also leads investigations and owns site quality program procedures.
What education and experience are required?
The listed options are doctorate plus 2 years, master's plus 4 years, bachelor's plus 6 years, associate's plus 10 years, or high school/GED plus 12 years of directly related experience.
What skills does the role require?
The listing calls for project management, cross-functional leadership, communication, data trending and evaluation, and the ability to evaluate compliance issues.