Document Controller

Orange, NJ

Post Date: 10/20/2017 Job ID: 7827 Industry: Pharma Pay Rate: $22.00 - $22.00

SUMMARY

The responsibility of the Quality Assurance Document Control Coordinator is to assist the QA Manager with the implementation, management and administration of the quality system - quality documentation in accordance with cGMP



RESPONSIBILITIES

  • In charge of the day-to-day operations of the document control.



  • Driving, executing and tracking record and documentation processes throughout the documentation lifecycles.



  • Auditing batch records.



  • Checking environmental, water and swab results. Alerting management if any failure.



  • Coordinating and facilitating implementation of corrective actions.



  • Preparing and processing status reports, assigning and monitoring document numbers, and reviews. Documenting for accuracy and completeness. Ensuring that change control discipline is followed.



  • Providing accessibility to all documents while protecting their security.



  • Writing and revising SOPs as assigned.



  • Providing support during audits.



  • Calibration of equipment.



  • Coordinating corrective action with suppliers and maintaining supplier service log.



  • Completing miscellaneous tasks and special projects as per management request.





QUALIFICATIONS

  • Minimum High School Diploma, Bachelor preferred



  • Prior experience in GMP-regulated industry is preferred, experience in Medical Office and documentation



  • Strong attention to details and very organized



  • Strong user of MS Office (Word, Excel, Power Point) as well as skills with Adobe Acrobat, data entry, scanning documents, filing.







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