• maintain quality records in appropriate location.
• capture training logs/roster for the site.
• training database 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 shipping 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.
minimum requirements:
* must have: visa b1/b2 & passport.
* availability to travel - 30% traveling request.
* experience with gmp and gdp, clean room environment.
* medical device manufacturing environment.
* proficient with microsoft programs and other basic computer applications.
* ability to communicate effectively internally 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.
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