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$20/hour
1030 1/2 San Fernando Rd, San Fernando, CA 91340, USA
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ShareThe 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 Version Control • Monitor and enforce proper version control practices, ensuring that obsolete or superseded documents are promptly removed from circulation.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 an hour Hours: 7a.m. to 3:30 p.m.
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26265 12 Trees Ln NW, Poulsbo, WA 98370, USA