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Gescript ProBio

Document Control Specialist/Manager


· 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



· 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


Jeanine Ji


July 31, 2023


United States

International Employee

Sponsor H1b

Sponsor O1

Working Style




New Jersay

Upcoming Conference

Nov. 12th, 2022

BioPacific Conf.

The BioPacific Conference is the annual flagship event of the CABS. Our mission is to bring scientists, executives, and bio-pharmaceutical professionals from the Pacific Rim countries together to discuss the latest advances in the world of life sciences, the unprecedented challenges and promises facing the industry, and the breath-taking developments and opportunities in Asia/Pacific countries

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Resilience and Ingenuity -- Embracing Opportunities in a new Normal

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