Document Control Specialist TEMP to PERM

Billerica, MA

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Job Description

 POSITION SUMMARY:

Coordinates, implements and maintains the company’s Document Control and Training System.   Stores, manages and tracks company documents and records.  Scans, images, organizes and maintains documents per company’s document lifecycle procedures and archives inactive records per the record retention policy.  The Doc Control Specialist acts as a document release gate, ensuring that all release requirements are satisfied and executes the document release transfer.  As part of release transfer, the Doc Control Specialist updates document tracking registries (SharePoint), coordinates training assignments and notifications, and records the release activities.  Other responsibilities include maintain the flow of both electronic and hard-copied Batch Records, department files for internal and external audits, and Deviations for traceability and reporting.  Must be able to recognize problems (within aforementioned workflows) and support actions to resolve them.

Position reports to the Director of Quality

ESSENTIAL FUNCTIONS:

  • Responsible for overall coordination of controlled documentation within the company
  • Create or help with preparations of formal documentation or approval workflows
  • Review documents and workflow for release acceptability
  • Ensure correct and adequate signatories are listed on change order form.
  • Coordinate and chair change request (CR) meetings to ensure proper document releases
  • Coordinate training activities with trainer and send out training notifications to trainees
  • Provide support and assistance with any of the company’s documentation processing or release activity, records generation or keeping, or related processes and subsystems
  • Participate in or assist with Internal and External Quality Audits
  • Assist in supporting external audits, coordinate activities in the background and ensure timely response to documentation requests from auditors
  • Provide additional support for Quality System operation and activities 
  • Notify suppliers of document changes for product made outside RainDance
  • Coordinate labeling activities through change management, interfacing with internal customers to meet quality standards and timelines
  • Order external standards and maintain tracking system
  • Perform self-audits of DMR records and ensure that the current revision is available in a timely manner
  • Investigate and respond to corrective actions related to Document Control, Training and External Standards
  • Train employees on the RainDance Change Request (CR) process
  • Perform other duties as deemed necessary by the supervisor




Skills/Requirements

 QUALIFICATIONS:

 Required:

  • High school graduate or higher
  • Minimum of 2 to 5 years document control experience in the Medical Device industry or related field (e.g. Diagnostics, Life sciences) 
  • Familiarity with Diagnostic or Medical Device manufacturing environment and associated compliance expectations for document control change control, source file handling, formatting, etc. and records management
  • Must be well organized, detail oriented, have strong time management skills, and possess the ability to multi-task
  • Must have strong interpersonal, communication (verbal & writing) and customer service skills 
  • Must demonstrate a high level of professionalism, as regular communication with internal and external business partners is required
  • Proficiency in the use of MS Office products

Desired:

  • MS SharePoint or other software used for change control (e.g. MasterControl, Trackwise…)
  • Previous experience with start-up environment (shifting priorities), must be flexible with other job duties as needed
  • Experience in preparing for, supporting, and directly participating in compliance audits

 

RainDance Technologies is “An equal opportunity employer”

 

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