Quality Assurance Document Control Specialist

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Quality Assurance Document Control Specialist

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    Quality Assurance Document Control Specialist
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Quality Assurance Document Control Specialist                                   

Summary for Quality Assurance Document Control Specialist

The purpose of this job is to support the Quality Management System (QMS) and assure that all controlled documentation for products are in compliance with current Good Manufacturing Practices (FDA), ISO 13485, EU and Health Canada regulatory requirements.

Job Functions for Quality Assurance Document Control Specialist

  • Under the direction of the Head of Quality, the Document Control Specialist is responsible for supporting all the documentation and training needs
  • Lead the Company's training program for all employees by monitoring, scheduling, and documenting training.  Train new quality assurance staff as needed
  • Provide documentation and training coordinator services including numbering, version control, formatting, processing, and filing of documents
  • Create training profiles, update training profiles on paper and electronic system, create training reports, maintain training records, etc.
  • Perform administrative functions in our training tracking system: update training profiles, updates documents records, etc.    
  • Assist with documentation and training projects
  • Document issuance, version control, manual and electronic files maintenance, and document status notifications
  • Creating monthly metrics
  • Follow-up on documents biennial review process
  • Review, scan, and file batch records
  • Document formatting, printing and update document trackers
  • Contribute to the maintenance of the Company's process deviation, NCR, CAPA and Complaint systems, and verify implementation of corrective actions to ensure continuous improvement
  • Maintain the quality documentation system in a state of inspection readiness by ensuring ongoing compliance with FDA, ISO 13485, EU and Health Canada requirements

Knowledge, skills and ability for the Quality Assurance Document Control Specialist

  • Thorough knowledge of cGMP, GLP, and GCP principles is required, as well as knowledge of ISO 13485, European, and health Canada regulations. Experience with Quality Systems and Internal and External Auditing
  • Bachelor's degree in biology or a related life science
  • Minimum 1 year experience is required in a cGMP quality, regulatory, and/or medical device manufacturing environment
  • Microsoft Suite detailed knowledge is must
  • Familiarity with style and formatting within MS word is must
  • Ability to interact positively and effectively with other departments within the organization (e.g., R & D, Manufacturing, QC)
  • Ability to adapt quickly to changing priorities and projects
  • Ability to work independently on assigned projects with minimal supervision
  • Ability to remain calm and poised under pressure as when confronted with audits from outside Regulatory agencies (FDA, ISO)
  • Experience with  electronic document systems a plus

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