Manufacturing Document Specialist II

Responsibilities

• Collaborate with the Quality department to manage and track Change Requests
• Create or revise new materials, material specifications, and production/QC procedures
• Review documents for format, accuracy, and compliance with existing procedures
• Create and revise label specifications in Label Content Records (LCRs) and templates
• Maintain the Document Storage Area for all controlled documents
• Conduct manual creation of Recipe and BOM setup on SAP
• Troubleshoot label printing issues to ensure timely product release
• Create department SOPs, Work Instructions, and packaging/dispensing procedures
• Perform Product Lifecycle Management (PLM) system changes and document routing
• Train new Documentation Specialists and support knowledge sharing

Requirements

• Bachelor’s degree or equivalent (science field preferred)
• 3-5 years of experience in a regulated industry (medical device, pharmaceutical, or biotechnology preferred)
• Strong knowledge of Good Documentation Practices (GDP)
• Proficiency with ERP systems, specifically SAP
• Proficiency in Microsoft Office (Word, Excel, and Visio)
• Knowledge of medical device regulations such as QSR and ISO 13485
• Strong oral and written communication skills
• Excellent problem-solving, organization, and multitasking abilities

Preferred Qualifications

• Formal training or certification in CAD or Solidworks
• Experience with desktop publishing tools such as AutoCAD

Benefits

• Competitive medical plans for you and your family
• 401k with profit sharing and employee stock purchase program
• Paid parental leave and paid time off
• Student debt relief program and education benefits
• Mental health platform and wellness support
• Fertility offering with stipend and pet insurance

About the Company

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As a global leader in life sciences, we develop, manufacture, and market a broad range of high-quality research and clinical diagnostic products to help people live longer, healthier lives.