Quality Assurance Specialist
Aviso de fuente externaen Infotree Global Solutions
Quality Assurance Specialist role involving validations, equipment qualifications, quality systems, 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
Infotree Global Solutions is seeking a Quality Assurance Specialist with experience in validations and commissioning and qualifications of manufacturing and laboratory bench equipment.
Responsibilities
- Review and approve product MPs, technical documents, work orders, EMS/BMS alarms, risk assessments, and change controls.
- Approve process validation protocols and reports, environmental characterization reports, planned incidents, and nonconformance investigations and CAPA records.
- Release sanitary utility systems, provide lot disposition, and authorize lots for shipment.
- Lead investigations and site audits, represent QA on the NPI team, and own site quality program procedures.
- Request Quality participation on the incident triage team and serve as designee for the QA manager on local CCRB.
- Support automation activities and facilities and environmental programs.
Requirements
- Education: doctorate; or master's degree plus directly related experience; or bachelor's degree plus directly related experience; or associate's degree plus directly related experience; or high school/GED plus directly related experience.
- Experience with IOQ, PQ, and functional testing; technical writing; quality systems, including deviations and change control; and maintenance knowledge, including PM, work orders, and job plan review and approval.
- Knowledge of reviewing and approving technical documents, including reports, technical reports, procedures, and forms for process and cleaning validation.
- Project management, organizational, cross-functional leadership, influencing, and negotiation skills.
- Strong knowledge in the area of expertise and of processes involved in manufacturing and distribution, QA, QAL, and validation.
- Ability to follow assignments through to completion and collaborate and coordinate with higher-level outside resources.
Datos clave
- The role includes validating and qualifying manufacturing and laboratory bench equipment.
- Education options range from doctorate to high school/GED with directly related experience.
- Responsibilities include leading investigations and site audits.
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Preguntas frecuentes
What does the role involve?
The role includes equipment validations and qualifications, quality systems, investigations, audits, and lot disposition.
What education is required?
The listed options are a doctorate, or a master's, bachelor's, or associate's degree paired with directly related experience, or high school/GED paired with directly related experience.
What experience and skills are sought?
The listing calls for experience with IOQ, PQ, functional testing, technical writing, quality systems, and maintenance. It also lists project management, organizational, leadership, influencing, and negotiation skills.