Document Control Specialist

4 weeks ago

Ventura, United States Administrative and Accounting - Quest Staffing Services Full time

Job Description

Job Description

POSITION DESCRIPTION Position Title: Document Control 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 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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