Overview
Document Control Specialist Jobs in Winston-Salem, NC at ProKidney Corp.
Title: Document Control Specialist
Company: ProKidney Corp.
Location: Winston-Salem, NC
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.
