Document Control Specialist

Company Name: Apex Resource Technologies
Location: Massachusetts

Responsible for the management and maintenance of the documentation system.

Duties and Responsibilities:

  • Manage the operation of the IQMS documentation control system in a timely fashion to ensure the latest revisions of documents are available and accurate records are kept at all stages of the process.
  • Participate in contract review to ensure job packets are designed to meet internal and customer requirement.
  • Perform Certificate of Compliance to ensure products are manufactured in compliance with regulatory and customer requirements.
  • Assist Document QA engineer with validation documentation activities ( preparing technical protocols and reports)
  • Act as a leader for process improvement projects regarding documentation.
  • Perform other duties as needed such as audits , inspections , data analysis to ensure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control method
  • Other duties as assigned

Skills/Qualifications:

  • Associate Degree or equivalent, or 2-3 years’ related experience and/or training , or equivalent combination of education and experience in documentation control in the medical industry
  • Strong Computer skills; Microsoft Office ( Word, Excel) and Minitab
  • Must have a strong attention to details
  • Leadership skills and team player
  • Highly organized
  • Ability to work with a high volume of documents in a fast paced environment
  • Strong written , verbal , time management and interpersonal skills

Physical Requirements:

  • Must be able to lift up to 25 lbs.
  • Must be able to sit or stand for long periods of time
  • Must be able to climb up and down stairs

Other Special Requirements:

  • Support cross functional teams and departments as required
  • Perform job duties in accordance to ISO 13485/9001 including ISO audits
  • Travel is required to support company initiatives

To apply, if interested, please submit a cover letter and formal resume to job060915@gmail.com