Document Control Specialist

3 weeks ago


Ventura, United States Quest Staffing Services, Inc. Full time
Job DescriptionJob Description

Primary Function

Coordinates, implements Document Control and Training System (eQMS). Follows established procedures and policies to meet the demands of document control in a regulated medical device company.

Duties/Responsibilities

  • Responsible for coordinating engineering change notifications (ECNs), facilitating review, approval, and retention of documentation in accordance with established procedures.
  • Coordinates and supports change control activities for labeling, specifications, artwork, manufacturing procedures, etc.
  • Assigns unique identification numbers to documents, parts, and components in accordance with established procedures.
  • Maintains laboratory notebooks and associated log sheets.
  • Coordinates record retention processes, ensuring compliance with company policies and regulatory requirements.
  • Supports Quality System training and maintains training records and training effectiveness documentation and records.
  • Performs self-checks/self-audits on document control and training activities and documentation at scheduled intervals.
  • Serves as global administrator of electronic Quality Management System, QT9.
  • Supports user requests for documentation.
  • Identifies and implements opportunities for process enhancements and efficiency improvements within the document control/Training function.
  • Other duties as assigned.

Special Knowledge

  • Experience in document control, ideally in regulated industries like manufacturing, pharmaceuticals, or medical devices.
  • Proficient in communication and working with teams that consist of diverse personnel and scattered locations.
  • Advanced English skills: writing, grammar, proofreading, redlining.
  • Technical proficiency and competence in document control software and other relevant technologies, such as electronic document management systems, Microsoft Office Suite, and data entry/typing.

Skills:

  • Exceptional organizational skills and attention to detail, with the ability to manage multiple tasks concurrently.
  • Strong aptitude for learning, with a growth mindset and eagerness to acquire new skills.
  • Understanding of best practices for record retention, storage, and archiving, along with compliance requirements.

Education/Training

  • Prefer Bachelor of Science or equivalent with at least 2 years’ experience in documentation control systems, 5-7 years without a degree with preference in coordination and administration of systems within FDA QSR/ISO regulated industry


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