DOCUMENT CONTROL SPECIALIST

Position Title: Document Control Specialist

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: QMS Manager

 

 

Summary

 

Lumicell is seeking a highly motivated Document Control Specialist to work in a dynamic, fast-paced start-up environment on a combination drug/device product. The successful candidate will play an integral role in commercializing the Lumicell System by organizing the documented history of development of its breakthrough cancer surgery solution. 

 

This position will be the key Quality resource responsible for administration of the quality document control process and ensure alignment with applicable standards and country specific regulations for a medical device/drug product. You will be a champion for quality and compliance in our business, integrating into all development and manufacturing functions to streamline documentation processes. This person will administrate the quality software system (Arena) ensuring documentation is maintained and compliant for business needs. This position will also play a supporting role in regulatory affairs activities, development of procedures, and coordination with different departments to ensure quality system requirements are met.

 

Responsibilities:

  • Administrate Arena quality software system and document control process, including acting as project manager to lead minor change control projects.
  • Coordinate and maintain controlled documentation both physically and electronically according to approved procedures.
  • Assist with file migration to storage, both physically and electronically, as applicable.
  • Coordinate and execute the migration of legacy documentation stored outside of the Lumicell eQMS into Arena.
  • Ensure all documents are current, properly identified, and maintained per applicable standards and regulations.
  • Aid in investigation and improvement initiatives for quality processes.
  • Review records and documents for completeness and compliance with FDA Quality System Requirements and ISO requirements.
  • Assist in companywide training on general quality principles and specific procedural requirements.
  • Other activities as assigned by supervision including cross-training in other areas of quality and regulatory as applicable.

 

Core Competencies:

  • Teach and lead others in developing quality skills.
  • Initiate and drive quality system process improvement.
  • Assist, coordinate and participate in quality system audits and regulatory inspections.
  • Conduct process quality measurements/evaluations.
  • Assists monitoring, analyzing and reporting trends in key quality metrics.
  • Ensures established department timelines are attained.

 

Qualifications:

  • Minimum of a bachelor’s degree in a life sciences, healthcare, or technology discipline (Preferred).
  • Experience:

    • Relevant experience in the medical device industry is required.
    • Familiarity with FDA medical device regulations and ISO 13485 is required.
    • Experience in QA document control process administration required.
    • Experience with effective project management preferred.
    • Minimum of 3 years Document Control experience working in an eQMS (Preferably Arena)
  • Knowledge & Skills:
    • Ability to read and interpret general technical/quality procedures and quality system regulations.
    • Ability to write and create medical device manufacturing SOPs and Work Instructions.
    • Ability to create reports, business correspondence, and procedure manuals
    • Ability to effectively present information and respond to questions verbally, in writing, and in group presentations
    • Must be skilled in Microsoft Word, Excel, Outlook and Power Point

 

Position Type/Expected Hours of Work

      • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
      • This is a Hybrid position, and the ability to be on-site 2-3 days per week is required.

 

Travel

      • No significant travel should be expected for this position

 

Supervisory Responsibility

      • This position has no supervisory responsibilities.

 

COVID Policy:

      • Lumicell has an implemented and strictly enforced a COVID Policy that’s intended to keep all employees safe when working on-site.
      • Lumicell has also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.

 

EEO Statement

      • Lumicell is an equal opportunity employer

 

Other Duties

      • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

To apply for this position, please send your resume to careers@lumicell.com.