What are the responsibilities and job description for the Document Control Specialist I position at Made Scientific?
About Made Scientific
Made Scientific is a U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors.
About the Role
The Document Control Specialist will play a critical role in supporting compliant document management operations across the organization. This role is responsible for issuing, reconciling, organizing, and archiving GMP and quality-related documentation while ensuring records are maintained in a state of audit readiness. The ideal candidate is highly organized, detail-oriented, and capable of managing sensitive documentation in a regulated environment.
Key Responsibilities
- Organize and maintain the document control room and document storage areas.
- Issue and reconcile controlled GMP documents including batch records, logbooks, QC testing forms, and training documentation.
- Create, organize, and maintain paper-based employee training binders.
- Receive completed documentation, scan records, and file documents in an organized and compliant manner.
- Maintain document traceability and archival records using spreadsheets and tracking systems.
- Ensure all controlled documents are inspection-ready and maintained in accordance with company procedures.
- Coordinate off-site document transfers, storage requests, and retrievals with archive vendors.
- Pack, ship, and reconcile archived records sent to off-site storage facilities.
- Track loaned archived records and follow up with requestors until documents are returned and reconciled.
- Support Quality Systems and cross-functional teams with document requests and administrative support as needed.
Quality & Compliance Support
- Ensure document management practices comply with GMP and company quality standards.
- Maintain confidentiality and integrity of controlled documentation.
- Assist during internal audits, customer audits, and regulatory inspections by retrieving and organizing requested documentation.
- Identify opportunities to improve document control workflows and organizational practices.
Qualifications & Skills
- Strong organizational skills with exceptional attention to detail.
- Ability to manage high volumes of documentation in a fast-paced, regulated environment.
- Excellent communication and collaboration skills.
- Proficiency with Microsoft Office Suite including Word, Excel, and Outlook.
- Ability to handle confidential information with professionalism and discretion.
- Experience in document control, quality systems, or GMP-regulated environments preferred.
- Previous experience in biotech, pharmaceutical, CDMO, or manufacturing environments is a plus.
- Associate’s or Bachelor’s degree preferred, or equivalent combination of education and experience.
Work Environment & Schedule
- This position is 100% on-site in Princeton, NJ.
- Work schedule will align with standard business operating hours.