Translation Project Coordinator

2 weeks ago


Rocklin, California, United States The Fountain Group Full time

Job Overview:

  • Compensation: $30.00 per hour, commensurate with experience, W2
  • Contract Duration: 12 months (Opportunity for conversion based on performance and budget considerations). (Onsite position required)

Key Responsibilities:

  • Engage in initiatives and assignments that foster continuous improvement and align with departmental and organizational objectives, particularly in relation to translation projects.
  • Assist in the upkeep of quality system documentation.
  • Evaluate submitted document modification requests to ensure compliance with established cGMP and other relevant standards. Provide constructive feedback and request amendments as necessary.
  • Manage documentation alterations within the document control system: Ensure the accurate and timely electronic capture and retrieval of quality documents and records while aligning with departmental goals.
  • Address inquiries and concerns raised by document Originators and Approvers promptly. Collaborate with Originators to follow up, analyze, and resolve outstanding change control issues.
  • Oversee product labeling and instructions for use, ensuring proper creation and updates. Implement labels according to quality protocols.
  • Maintain document control records upon completion, including scanning and filing tasks.
  • May undertake additional administrative responsibilities to support the Quality organization, such as filing, organizing, and cataloging records.
  • Support activities within the Document Control department.
  • Facilitate training for employees regarding Document Control processes, particularly those related to translation.
  • Adhere to regulatory and standard requirements applicable to the site, including MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.

Qualifications:

  • Minimum requirement: High School Diploma or GED; Associate's or Bachelor's degree is highly preferred.
  • Experience in translating documents using Google Translate or similar software is essential, with proficiency in multiple languages (1-2 years minimum; preference for 3-5 years).
  • Experience with Quality or Regulatory documentation is advantageous.
  • Background in Biotech, Pharma, or Medical Device industries is preferred.


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