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Documentation Specialist

San Diego Metro Area, CA

Post Date: 06/16/2017 Job ID: JN -062017-19298
Description:
Create, design & develop new, or improve existing, labeling documentation.
Manage documents to support Labeling Development in compliance with ISO, cGMP, and FDA guidelines, working within established formats and templates. Document types include: specifications, SOPs, manuals, quick reference guides, and label artworks (reagent, box, trays).
Identify areas for improvement (e.g., processes, styles, formats) & execute continuous improvement initiatives.
Maintain a high level of quality, clarity & consistency for all documents.
Organize & maintain department files, databases & spreadsheets.
Organize & create controlled labeling documents of a moderate complexity.
Initiate the collaborative review process.
Track documentation through the entire development process while adhering to strict timelines, maintaining revision control, maintaining change lists & managing reviewers.
Organize routine labeling documents.
Assist document users with inquiries & research.

Skills:
Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules.
Excellent attention to detail and high word processing accuracy.
Strong self-motivation and ability to work independently and in a team environment.
Advanced proficiency Word, Excel, and PowerPoint.
Excellent written and oral communication.
Strong follow up, organization and prioritization skills.
Experience working in a regulated, ISO, Good Documentation Practices and GMP environment is preferred. Experience with EDMS and workflows a plus but not required.

Education:
  • Bachelor's degree
  • Knowledge of documentation process and Good Documentation Practices is preferred.
  • Prior experience in a biotech or regulated industry is strongly preferred

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