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Document Control Specialist, FDA Regulations

3 months ago

Irvine, United States Marquee Staffing - OC Full time
Job DescriptionJob Description

Job Scope and Quality Impact:

The Document Control Specialist is responsible for collecting, maintaining, archiving, and retrieving all documents necessary to ensure compliance with company procedures and FDA regulations, as well as monitors production operations to ensure that all users have the latest accurate revision of appropriate documentation in a timely manner.

To ensure compliance with the company Quality System, ISO standards, FDA and Health Canada requirements, and City, County, State, Fire Marshall, and Federal safety regulations. Maintenance and improvement of policies and procedures focused on delivering products and services that are in compliance with company Quality Systems and regulatory requirements.

General Description and Duties:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Quality Systems:

  • Maintain and improve company quality systems in compliance with FDA, International Standards (ISO), Canadian, and other regulatory agencies. This function is responsible for supporting company quality compliance and to provide control of processes, materials, and products in compliance with the company Quality Systems

Document Control:

  • Works in Document Control for managing documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.
  • Comply with quality record retention, safeguard information, and retrieve the quality records more effectively.
  • Executes routine DCO change packages (e.g., process redlines, proofread, make corrections, and document training). Assign part and document numbers.
  • Provides guidance to other departments during the document change process.
  • Maintains control of electronic and hard copy for SOPs, product drawings, labeling, artwork, process validation, manufacturing procedures, design control, marketing and educational material and test reports.
  • Informs Vendors and Staff of document updates and provides controlled copies when applicable.
  • Uses GDP (Good Documentation Practices) to correct records or assist others in correcting records.
  • File, store, manage and track company documents for the Quality Management System.
  • Performs scanning, filing, copying to maintain documents and obsolete inactive or older revision documents.
  • Helps product development team maintain drawings, work orders, DCOs, etc.
  • Perform administrative tasks as required.
  • Releases DCOs, updates logs and lists.
  • Reviews documentation for completeness.
  • Files, organizes, archives, releases documentation both as hardcopy and electronic files.
  • Consult with engineering, operations, and other cross-functional teams for documentation requirements.
  • Verifies completeness of the DCO requirements prior to release of documents into QMS.

Requirements

  • Must have minimum education requirement of high school diploma, Bachelor's degree a plus
  • 2-3 years experience in document control role for regulated industry such as Medical Devices, Aerospace, or Pharma
  • Knowledge of Good Documentation Practices (GDP)
  • Excellent communication skills
Company DescriptionMarquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.

Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.

Apply with us todayCompany DescriptionMarquee Staffing has built a reputation on expert local market knowledge, unparalleled personalized service and the ability to deliver winning candidates and job opportunities.\r
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Marquee operates offices located conveniently throughout Southern California. Each branch is full-service, providing temporary, contract, contract-to-hire and direct placement services for a diverse set of clients. Each branch has recruiters who specialize in key industries, ensuring that our clients get the best match possible for each open position and that our candidates get expert guidance in their career path.\r
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Apply with us today