This position oversees Content and Labeling activities related to immunoassay products. Ensures requirements for labeling are met while maintaining compliance with regulatory and manufacturing regulations. In addition, the individual will represent the Content & Development Department as a labeling subject matter expert.
• Manage all aspects of labeling projects.
• Demonstrate proficiency and provide leadership through the label process to meet company strategies and business objectives.
• Oversee the correct, complete, and compliant execution of product labeling and resolve problems and exceptions.
• Develop and maintain labeling procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.
• Understand and monitor label team participation in change control.
• Assure department activities comply with established SOPs, best practices, and GMPs.
• Identify and lead process for obtaining feedback from key stakeholders for continuous improvements to label process.
• Drive continuous improvements through observation, measurement and root cause analysis/resolution.
• Represent the labeling team as a subject matter expert, on company teams, and as a resource for other departments. Coordinate activities with other supply chain departments.
• Develop and maintain tools to manage label team workflow.
• Performs additional duties or assignments as directed by management.
Qualifications: Scientific background knowledge, understanding of data and reports. A medical writer or medical technologist skill set for CH. On immuno there is a lesser need for this skill, more of a PM/lead.
• Minimum 5 years’ direct work experience leading projects or team in a medical device manufacturing company.
• Minimum 5 years’ experience with XML-based content management system (or equivalent), Adobe Frame Maker and InDesign (intermediate level).
• Abilities and skills in product/project management & organization
• Excellent verbal and written communication skills
• Must have strong collaboration skills, ability to interface with engineers, vendors and scientists.
• Ability to learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets and databases.
KNOWLEDGE of the Following is a Plus
Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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