Document Control Specialist

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.

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

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.

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