The role of Document/Change Control Specialist include, but are not limited to:
Document Management
Oversee the full lifecycle of controlled documents, including creation, review, revision, approval, issuance, and retirement.
Ensure documents are formatted, maintained, and distributed in accordance with company standards and procedures.
System Administration
Administer and maintain the company’s Document Management System (DMS), including user access, permissions, and periodic system updates.
Troubleshoot system issues and liaise with IT or vendors as needed.
Compliance & Audits
Prepare and provide documentation during internal, customer, and regulatory audits.
Ensure all controlled documents comply with applicable regulatory standards (e.g., FDA, ISO, cGMP) and company requirements.
Version Control
Monitor and enforce proper version control practices, ensuring that obsolete or superseded documents are promptly removed from circulation.
Document Archiving
Maintain both electronic and physical archives according to established retention schedules.
Index and catalog records to allow for accurate and efficient retrieval.
Change Control
Administer the Document Change Request (DCR) process to ensure that changes are reviewed, approved, implemented, and documented appropriately.
Record-Keeping
Maintain accurate records of product data, certificates of compliance, inspection reports, and other documents required for quality assurance and regulatory compliance.
Training Support
Train employees on document control procedures, proper documentation practices, and effective use of the Document Management System (DMS).
Provide ongoing support to ensure adherence to company documentation standards.
Key Skills & Qualifications
Attention to Detail: Ability to ensure accuracy, consistency, and completeness in all documentation.
Software Proficiency: Skilled in document management systems (e.g., SharePoint, MasterControl) and Microsoft Office Suite (Word, Excel, PowerPoint).
Quality System Knowledge: Familiarity with quality management systems (QMS) and regulated manufacturing environments, including FDA, ISO, and cGMP requirements.
Manufacturing Awareness: Understanding of manufacturing workflows and quality control principles to align documentation with operational needs.
Communication Skills: Strong interpersonal and written communication skills for collaborating with cross-functional teams and training staff.
Organizational Skills: Ability to prioritize, manage deadlines, and maintain meticulous records in a fast-paced environment.
Pay : $20.00
Hours: 7 a.m. to 3:30 p.m.
