Document Control Specialist
3 weeks ago
SpecialistReports To: Supervisor,
Document ControlDivision: Quality Review: Annual
Primary Function
Coordinates, implements, and maintain Document Control and Training System (eQMS).Follows established procedures and policies to meet the demands of document control in aregulated 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 accordancewith established procedures.• Maintains laboratory notebooks and associated log sheets.• Coordinates record retention processes, ensuring compliance with company policies andregulatory requirements.• Supports Quality System training and maintains training records and training effectivenessdocumentation and records.• Performs self-checks/self-audits on document control and training activities anddocumentation 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 efficiencyimprovements 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 andscattered locations.• Advanced English skills: writing, grammar, proofreading, redlining.• Technical proficiency and competence in document control software and other relevanttechnologies, 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 multipletasks 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 withcompliance requirements.
Education/Training.
• Prefer Bachelor of Science or equivalent with at least 2 years’ experience in documentationcontrol systems, 5-7 years without a degree with preference in coordination andadministration of systems within FDA QSR/ISO regulated industry
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