top of page
Gescript ProBio

Document Control Specialist/Manager

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

908-800-1477

Jeanine Ji

Expiration

July 31, 2023

Location

United States

International Employee

Sponsor H1b

Sponsor O1

Working Style

Onsite

Remote

Address: 

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

Back to Jobs

arrow&v

Previous Conference

Program 2021

Passion for Better Medcine

Leading Biotechnology and Innovation

Program 2019

Pursuing Science for Cure

Program 2018

Innovation, Collaboration and Globalization

Program 2022

Resilience and Ingenuity -- Embracing Opportunities in a new Normal

Back to Jobs

Close Site Navigation
bottom of page