Descripción y detalle de las actividades
- Maintain Quality Records in appropriate location.
- Capture Training logs/roster for the site.
- Training Data base handling.
- CAPA facilitator.
- Responsible to archive quality records (Training files, Logs, TCR, etc).
- Audit/verify documents are compliant with GDPs.
- Responsible for the distribution of controlled copies and retrieval when needed.
- Assess/Audit of current controlled documents are posted at site level.
- Scan DHR documentation prior to ship product to LLC for digital archiving.
- Prepare records for outside storage (Iron Mountain).
- Responsible for shredding obsolete/unused documents for the site.
- Responsible for the support on document translations.
- Purchase appropriate consumables for records shipping.
Experiência y requisitos
- Must have: Visa B1/B2 & Passport.
- Availability to travel - 30 % traveling request.
- Experience with GMP and GDP, Clean room environment.
- Medical device manufacturing environment.
- Ability to communicate effectively internal and externally with co-workers, and department management in both written and verbal form.
- Provide support on NHO preparation.
- Provide support with QA departmental purchases.
- Support Internal/External audits.
- Support with admin tasks.
- Support Environmental control activities such as providing cleaning logs to the employees, ID DI water samples, etc.
Beneficios
- Beneficios de acuerdo a la LFT
- fondo de ahorro
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Mixto
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
- Lunes a viernes
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Edad** 18 - 65 años
**Disponibilidad p. viajar** Si