Documentation Specialist

Currently I have an opening for a  Documentation Specialist  located in  Oceanside, CA.  Details for the position are as follows :

Job Description :

• Responsible for owning and overseeing all Site Operations documents through creation and revision, the Site Operations Documentation Specialist helps to define and adhere to documentation guidelines by managing document change requests, working closely with technical collaborators, redlining documents, and ensuring timely completion of all Site Operations change records.
• Their knowledge needs to be deep in Site Operations bioprocessing, document revision, the Quality / GMP change control process, and project management capabilities.
• Own and oversee the Facilities and Engineering document creation and revision process.
• Perform Change Owner responsibilities for Site Operations by managing process area and system change records including : quality actions, technology transfer changes, shutdown activities, inspection responses, and other Site Operations continuous improvements projects.
• Review all Site Operations revision requests and collaborate with technical experts and stakeholders to align on document revision prioritization, necessity, and improvement opportunities.
• Establish and implement business processes to optimize Site Operations document revision.
• Establish and implement documentation guiding principles that align with site training strategy, tech transfer readiness, and adhere to GMP regulatory requirements.
• Collaborate with Site Operations SMEs and technical assessors for document creation and revision.
• Redline documents using technical knowledge and knowledge of SOP’s Act as Veeva and Eval Subject Matter Experts.
• Bachelors degree required, 3 years of experience in a GMP setting performing documentation revisions / documentation management / technical writing. Experience with TrackWise, Condor, or Veeva is preferred!

Technical Information :

Salary : $35 - $41