Document Control Coordinator

Job Summary The Documents Control Coordinator serves as a documentation technical resource to the plant and is the primary point of contact for controlled documents and related processes. Essential Functions Oversees and administers the controlled document process for the site, ensuring compliance with FDA regulations and company policies. Serves as the DMS administrator for the software system used to electronically house the site’s documents. Provides training to employees on how to use the system. Coordinates DMS projects and improvements. Processes and administers controlled documents promptly. Provides word‑processing assistance to departments to ensure controlled documents and batch records are formatted consistently. Monitors completion status of periodic reviews and change‑control action items to ensure timely documentation and maintain compliance. Periodically audits master copies of documents to ensure issued copies are current. Enters revised documents into the Learning Management System on time for training. Proofs finished lot labels and batch records, and backs up label administration duties. Supports annual DMF updates. Provides support to investigations and out‑of‑specification events for product disposition. Supports intermediate labeling and tank inspections as needed. Additional Department Functions Performs administrative duties such as mail distribution, supplies coordination, and maintenance of fax and copy machines. Participates in a certified 5S Workplace System for housekeeping and organization. Minimum Requirements Education: High school diploma, GED, or equivalent required. Associate or technical degree or higher preferred. Experience: 1–3 years in pharmaceutical manufacturing preferred. Competency in MS Word, Excel, and Adobe required. Experience with an electronic document system preferred. Skills: Organization, follow‑through, effective communication, computer literacy, action orientation, conflict management, customer focus, technical skills, presentation skills, priority setting, and written communication. Relationship With Others / Scope Reports to the Site Quality Director; consults with all levels of plant personnel on issues and projects, and interacts with personnel from other locations within Mallinckrodt. No direct reports. Working Conditions Generally normal office and meeting rooms, with occasional routine assignments in plant and non‑air‑conditioned production environment. Exposure to fugitive emissions of typical chemical operations. Some travel may be required. Personal protective equipment must be worn as directed by EHS, leadership team, or safety guidelines. EEO Statement We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. #J-18808-Ljbffr Paladin Labs Inc.