Spring Point Project is committed to improving the lives of people with Type 1 diabetes by providing a virtually unlimited supply of medical-grade, high-health pigs to serve as safe islet cell donors to people with diabetes.
We envision a world without diabetes, a world where monitoring and daily insulin injections are no longer a part of anyone's life.
Position Title Document Control Specialist
Position Objective The Document Control Specialist reports directly to the Director of Quality. The Document Control Specialist supports quality assurance activities by reviewing records and documents for accuracy, completeness, and adherence to Spring Point Project quality management system, customer requirements, and cGMP and cGDP regulatory requirements.
The Document Control Specialist performs document management, tracking, and administrative support tasks for controlled document record systems as well as other tasks to assure the schedules and goals of the quality system are met.
Status Non-exempt
Accountable to Director of Quality
Key Responsibilities and Duties
Responsible for overall Quality Assurance (QA) document control coordination and functions, including document logs, tracking, processing, review, distribution, release, scanning, and archiving of documents per applicable SOPs and regulations
Coordinate the revision, review, and approval and retirement of controlled documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), batch records, and worksheets
Responsible for ensuring biennial review and continuous improvement review of all controlled documents
Maintain SOP binders, paper-based logs, and controlled notebooks
Organize and ensure accurate and reliable filing systems for all paper-based and computer-based GxP documents
Maintain training records and ensure timely completion of scheduled training. Maintain change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents
Maintain equipment records and other paper-based quality records
This job description is representative of the types of duties and responsibilities that will be required of positions given this title and should not be construed as a declaration of the sole duties and responsibilities of any particular position. Employees may be directed to perform additional job-related tasks other than those specifically presented in this description
Qualifications and Experience
Quality professional with a minimum of 1-3 years of experience performing document management in a regulated pharmaceutical or medical device industry with document control experience
Demonstrated knowledge of ISO and FDA/Quality Systems such as cGMPs, 21 CFR 210, 211, 11, and 820 and other regulatory agency requirements sufficient to apply to quality operations and compliance
Must be proficient in the use of computers and Microsoft 365 applications such as Word, Excel, PowerPoint, and additionally Adobe Acrobat. eQMS and/or Monday.com experience a plus
Must be extremely well-organized with strong communication skills both verbal and written
Ability to work independently or on teams
Can maintain attention to detail while executing multiple tasks
Must be self-motivated with ability to handle, organize and prioritize multiple tasks to meet deadlines
Ability to effectively build and maintain interdepartmental communication and relationships both in-person and hybrid
Audit or inspection experience a plus
Project management experience a plus
Education:
Bachelor's or Associate degree in a related skill (Preferred)