Documentation Specialist in San Diego, CA at Apex Life Sciences

Date Posted: 2/15/2018

Job Snapshot

  • Employee Type:
  • Location:
    San Diego, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Our client, a leader in rapid point-of-care diagnostics is seeking a document specialist. This role will support the R&D department in specific design control activities. Specifics of the job are as follows:

  • Aid in writing, formatting and subsequent processing of documents (SOPs, MPs, RMS, Labeling) relating to the implementation of new products that are under design control.
  • Write/update procedures by using a template/feedback provided by a subject matter experts (R&D, Quality, Operations).
  • Initiate required forms to process the documents through an electronic or paper based document management system.
  • Communicate with extended team and vendors to ensure alignment of various document related information (Part Number, Descriptions, Bill of Material Data, CofC or CofA Data).

 Preferred experience/education:

  • Bachelors Degree in engineering discipline or equivalent experience.
  • 1-2 years of Document Control experience in an FDA regulated environment, preferably medical devices and/or in vitro diagnostics.
  • Experience with revision control.
  • Experience in a GMP type environment (production, lab) preferred.
  • Knowledgeable of federal and other regulations, e.g. QSRs, ISO, ISO 13485, CMDR.
  • Experience with 21 CFR 820, ISO 13485.

 Profile of qualified candidate:

  • Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc. 
  • Demonstrates commitment to the development, implementation and effectiveness of Ameditech's Quality Management System per ISO, FDA and other regulatory agencies. 
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. 
  • Must be flexible and adapt to changes. 
  • Ability to multi task and set priorities independently. 
  • Must be organized and extremely detail oriented. 
  • Must be able work independently but comfortable interacting independently with various groups within the company. 
  • Must be motivated and willing to take on challenges. 
  • Takes initiative to problem solve and communicate with extended team members.
  • Proficient in MS Word/Excel. 
  • Experience with Document Control databases such as Ensure, Agile, ect. 
  • Strong communication skills. 
  • Ability to work in a fast paced environment.