Responsibilities

· Implement document control system for GMP operation

· Establish document initiation, review, approval, distribution, archive processes

· Review submitted document drafts for format, typo, content

· Distribute documents to reviewers for comments

· Collate reviewer comments and feedback while maintaining track change

· Finalize final version of documents, ensure required training is completed before making documents date effective

· Distribute documents to required users, collect old revisions when new revisions are issued

· Archive old revisions according to filing system

· Ensure document quality meets intended use, including GMP production, QC testing, quality systems execution, and regulatory filing

Qualification

· BS in life science or related field

· For Specialist position: 3+ years experience in document control under FDA regulated industry. For Manager position: 7+ years similar experience.

· Good command of MS Word utilities, including page setup, formatting, template creation, SmartArt, form creation, bookmarking, graph and chart creation

· Familiar with GMP operational principles and practices

· Experience with regulatory submission documents a plus

· Works independently, self-motivated

Ability to work across lines of authority