Document Control Specialist
Zyomyx - Fremont, CA

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Zyomyx, Inc. is a privately held diagnostics company – a developer, manufacturer and marketer of innovative point-of-care diagnostic products. Our first product, the revolutionary MyT4 POC CD4 diagnostic test for HIV/AIDs in the developing world, will contribute to saving millions of lives in developing countries around the world. However, while Zyomyx focuses INITIALLY on this key core product, we also know that incredible future potential opportunities exist from our other various core technology platforms to bring complex lab diagnostics into POC, a growing and burgeoning worldwide market. As a result, the Company will launch follow-on products for launch in markets of high income countries over the coming years.

DOCUMENT CONTROL SPECIALIST
Are you naturally meticulous, detail-oriented and consistently accurate? As our Document Control Specialist, you will be responsible for managing document control processes, reviewing and ensuring the accuracy of released documents, and for coordinating the distribution and maintenance of all documents and records required for the Zyomyx Quality System.

POSITION RESPONSIBILITIES INCLUDE:

  • Manage DCO processes: monitor status of documents, route documents for review and approval, provide status updates and required follow-up to ensure timely completion of documentation
  • Log and assign control numbers (parts, documents, equipment etc.), descriptions and their revision levels
  • Identify and implement improvements to the document control system
  • Review process documents and quality control records for accuracy and deviation from the norm, follow through on potential corrective actions, and help resolve documentation related issues
  • Compile and organize executed batch records and quality control documentation in DHRs
  • Maintain Device Master Records (DMRs), Device History Records (DHRs) and Design History Files (DHFs)
  • Participate in orientation and training of document users on the Document Control Process
  • Manage and maintain employee training records
  • Compile and maintain External Standards
  • Issue and archive Laboratory Notebooks

EDUCATION AND SKILLS REQUIREMENTS:

  • Associate’s or Bachelor’s degree, preferably in a scientific discipline (e.g. Biochemistry, Chemistry, Materials Science, or Medical Devices)
  • 3+ years experience within an FDA and/or ISO regulated medical device environment
  • Working knowledge of medical device and quality system regulations/standards for document control (i.e. FDA QSR, ISO13485)
  • Excellent verbal and written communication skills
  • Proficiency with Microsoft Office Suite of applications
  • Ability to effectively document procedures and processes, and at ease with reviewing technical documents
  • Outstanding attention to detail, with ability to maintain extreme attention to details
  • Ability to maintain a methodical approach and high level of organization in all aspects of work
  • Excellent inter-personal skills and proven ability to work collaboratively with and across all functional areas of the organization (Engineering, R&D, Manufacturing, etc.)
  • Proven ability to handle multiple competing priorities in a fast-paced work environment
  • Prior experience with document control software or ERP systems
  • Prior auditing experience

If you are up to the excitement and challenge of continuing the success of Zyomyx, and in joining a phenomenal team that is on a driven mission to significantly and positively impact lives globally, submit your resume


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