Documentation Specialist

Department: Quality
Reports to: Director of Quality

The Documentation Specialist is responsible for all activities required in the maintenance of documents associated with the Quality System. The position will execute revisions; distribute requested documents and control library and archiving activities. As a member of the Quality Assurance staff, the Documentation Specialist will be an active participant in external audits and will develop and maintain accurate audit records.

Strategic Focus

  • Maintain effective collaboration with internal colleagues to meet corporate objectives and drive improved business results
  • Design and implement programs, materials and activities which support the growth efforts of the Company
  • Maintain cost discipline within assigned programs

Specific Responsibilities

  • Edit and master current documents as well as perform obsolescence and retention of revised documents
  • Issue manufacturing and packaging directions to meet production schedule requirements
  • Execute the bi-annual review process in accordance with the SOP
  • Maintain the library of referenced external standards
  • Archive required quality records including change controls, validation reports, lab notebooks, metrics reports, batch records, training records and technical reports
  • Act as Training Coordinator and maintain training records
  • Maintain current document facility
  • Participate in external audits as assigned in compliance with SOP requirements
  • Perform other related duties and projects as assigned


  • Bachelor’s degree in the life sciences, business or related field
  • Minimum of 5 years in the pharmaceutical or medical device industry
  • Minimum of 3 years experience within QA or document control
  • Understanding of FDA, ISO 13485:2003, cGMP, QSR and MDD standards
  • Proficiency with Microsoft Office Suite

Desired Experience, Knowledge and Skills

  • Highly organized and able to prioritize workflow daily and execute on multiple priorities
  • Excellent verbal and written communication skills
  • Ability to work autonomously, effectively manage time and deliver results on time
  • Prior experience managing database systems

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