Document Control Specialist

The Document Control Specialist manages document workflows through respective document life cycle utilizing MasterControl Digital Document Management System.  . This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced, dynamic environment. Responsible for activities related to guidance, identification, collection, distribution, review, and filing of controlled documentation (Batch/Production Records, Logbooks, Forms, etc.) within GMP Manufacturing.

Essential Duties & Responsibilities:

• Ensure that controlled documentation supporting GxP operations is formatted, current, accurate, and processed in a timely manner
• Provide guidance to Manufacturing and Quality personnel as it relates to GMP/in plant GMP documentation
• Perform routine and ad hoc document control metric reporting and analysis.
• Identify continuous improvement opportunities
• Participate in problem solving meetings
• Oversee issuance and storage of controlled documents.
• Manage, organize, and maintain all Quality document storage of controlled documentation
• Provide copies of controlled documents to ProKidney staff on an as needed basis
• Provide timely and accurate, right the first time GMP document review
• Support internal and external audits and regulatory inspections
• Review and identify documentation discrepancies
• Collaborate with internal resources to efficiently and effectively resolve documentation related issues
• Initiate and/or assist with quality records in Quality Management System (QMS) as needed
• Scan and enter documentation into Quality Management Systems (MasterControl) as directed
• Assist and comply with Quality Assurance documentation functions
• Adhere to internal/external guidelines, specifications, and regulatory requirements while reviewing documentation
• Comply with company policies and procedures

Education And Experience:

• 0 - 2 years of relevant hands-on document management experience.
• Associates degree from an accredited college or university or a combination of equivalent education and applicable job experience.
• Demonstrate understanding of cGMP, GDP, and QMS
• Ability to learn and understand technical aspects within documentation
• Ability to maintain positive cross-functional and collaborative relationships
• Ability to maintain a positive attitude and ability to perform under pressure
• Ability to exercise judgment within defined practices and policies in performing document control functions with input from supervisor.
• Must be highly organized
• Must be a team player
• Demonstrated ability to problem solve
• Strong communication skills, including both verbal and written