QA Documentation Specialist I (Records Room)

December 13, 2018 | Charlottetown, Prince Edward Island (Canada) | Quality Assurance and Regulatory Compliance

Scope: To organize and maintain record storage room according to Records & Retention procedure. To control release and retrieval of records. To administer the document discontinuation process. To administer file numbers for OOS, Risk Assessments, No Trend and FMEA. To maintain historical file of inserts for laboratory materials. To maintain historical file system for all controlled documents inside and outside the Electronic Document Management system (CATSWeb). To create, revise and file controlled documents inside and outside the CATSWeb Document Management system.

Responsibilities:

May include some or all of the following:

  • Organize and maintain filing/archiving systems for controlled documents (i.e. Batch Records, Design History Files, Risk Management).
  • Retrieve files as requested from the Records Room and log in/out to ensure timely return to the Records Room.
  • Issue numbers for OOS, Risk Assessments, No Test and FMEA. 
  • Maintain Batch Record Review folder and index.
  • Scan controlled documents and file in Records Room (i.e. Batch Records, LTSs, Validations and Verification's).
  • Coordinate the systematic collation of documents related to discontinued products for proper filing, archiving and obsoleting documents in CATSWeb Document Management system.
  • Purge documents as per the Records & Retention procedure.
  • Obtain copies and maintain historical file of inserts for laboratory materials (calibrators, controls, linearity materials, etc.)
  • Create and/or revise and file controlled documents according to procedures inside and outside the CATSWeb Document Management system.
  • Complete Certificate of Analysis records to accompany customer orders.
  • Obtain internal approval of customer supplied specification documents and file appropriately.
  • Assist in sending confidential documents outside of SDC according to procedure.
  • Other tasks as required.

Education / Experience: 

  • Requires a high school diploma or equivalent with 4 years of related experience.
  • A college diploma in administration is preferred
  • Experience working in a regulated environment.

Skills / Pre-requisites:

  • Knowledge of Microsoft Office Suite required.
  • Electronic document management system preferred.
  • Excellent organizational skills.
  • Ability to work in an environment which requires extreme attention to detail.
  • Fast, accurate typing skills.

Sekisui Diagnostics is a global company that understands the value of their employees. You will be part of a team that is built on strong core values. Sekisui Diagnostics offers a competitive salary, a competitive benefits package, and opportunities for professional growth to help you develop your skills to be successful in your career.

Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted.

By selecting apply now you will be leaving the Sekisui Diagnostics web site.

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