This person will be processing DCR's (also known as ECOs/DCOs) for a large project for ERP.
Must have:
4 plus yrs in a Document Control Specialist role (pharma or med device), regulated industry
Must know how to use Word - format already existing documents and new docs to specific requirements.
Sense of urgency - as there will be deadlines.
Good Document Practices (GDP)
Possess good organizational skills
Nice to have:
CATSWeb experience
Job Summary
The Quality Document Coordinator is an individual contributor who is responsible for conducting day to day processing of controlled documents for cGMP operations. Responsible for compliance in accordance with Document Management procedures and will assist with ongoing Quality documentation deliverables driven by business objectives and identified by management.
Job Responsibilities
Coordinates, proofreads, formats, and troubleshoots issues for controlled documents supporting the manufacturing and testing of products.
Balances and prioritizes assigned documents to ensure meeting document change request due dates.
Aligns with all levels of the organization to meet the needs of documentation system users on site and at external facilities.
Manages multiple tasks in a fast paced and dynamic environment while maintaining focus on quality and compliance with local SOPs, policies and directives, and regulatory requirements.
Supports individual and group training sessions for system users on making document changes and reviewing electronic reference copies of documents.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Actively demonstrates the company values of accountability, quality, efficiency, customer service, collaboration and safety.
* In the case of absence the reports to Manager above or a peer incumbent will function as a backup for this position.
Education & Qualifications
AS in English or Science.
A combination of education, training and experience may be considered in lieu of the above stated qualifications.
4-6 years of experience in the pharmaceutical industry, preferably within Quality or Documentation function
Prior experience with Electronic Documentation Management System is preferred
Proficient in Microsoft Office
Proficient in advanced functions of Microsoft Word.
Excellent verbal and written communication
Ability to work independently,
Able to identify and present solutions that will resolve issues and meet the required due dates for documents