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Gmp Document And Records Management Specialist
Join us in pioneering breakthroughs in healthcare. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This role is responsible for ensuring the site's GMP Document and Records Management process is followed within the document management system, including electronic documents and records. This includes supporting site functions to maintain clear, accurate, and compliant Quality Management procedures. This role ensures all documentation aligns with regulatory standards, internal quality systems, and customer requirements. Responsibilities: This position requires solid understanding of the document control lifecycle within the medical device/IVD industry, including management of paper and electronic documents and records including, approval, versioning, distribution, archiving, obsolescence, metric tracking, and training delivery. Maintain a variety of technical documents within the Quality System including: Standard operating procedures (SOPs), Work Instructions, Associated GMP record Troubleshoot issues within the electronic document management system, ensuring document accuracy and alignment with processes Ensure documentation complies with applicable regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR) Provide training, support and guidance to organization as needed Serve as the document control representative on projects and global teams Maintain controlled documents in document management systems (approval, versioning, distribution, archiving, obsolescence) Revise documents for both technical and non-technical audiences, adapting content to meet user needs and regulatory requirements Performs and/or supports internal and/or external audits as required Performs other related duties and projects as business needs require at direction of management Perform records management duties as needed Perform data collection and analysis to create and maintain quality metrics for review, identification, and escalation of document and records control trends and areas of improvement. Your expertise: Bachelor's degree in Life Sciences, Engineering, English, Technical Writing, or related field 2+ years of experience in technical writing within a regulated industry (preferably medical devices, pharmaceuticals, or biotech) Familiarity with Medical Device and IVD regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR) Solid knowledge of regulated and GMP document control lifecycle (approval, versioning, distribution, archiving, obsolescence) Exceptional written, proofreading, organizational and verbal communication skills with acute attention to detail Strong communication and interpersonal skills, with the ability to collaborate across multiple departments Ability to multitask and manage multiple priorities in a fast-paced environment Proficiency with MS Office (Word, Teams, Visio, Excel, PowerPoint), Adobe Experience with Electronic Quality Management Systems a plus This position is a 5 day a week, in-office position located at our Newark, DE, site. We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Join us in pioneering breakthroughs in healthcare. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. This role is responsible for ensuring the site's GMP Document and Records Management process is followed within the document management system, including electronic documents and records. This includes supporting site functions to maintain clear, accurate, and compliant Quality Management procedures. This role ensures all documentation aligns with regulatory standards, internal quality systems, and customer requirements. Responsibilities: This position requires solid understanding of the document control lifecycle within the medical device/IVD industry, including management of paper and electronic documents and records including, approval, versioning, distribution, archiving, obsolescence, metric tracking, and training delivery. Maintain a variety of technical documents within the Quality System including: Standard operating procedures (SOPs), Work Instructions, Associated GMP record Troubleshoot issues within the electronic document management system, ensuring document accuracy and alignment with processes Ensure documentation complies with applicable regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR) Provide training, support and guidance to organization as needed Serve as the document control representative on projects and global teams Maintain controlled documents in document management systems (approval, versioning, distribution, archiving, obsolescence) Revise documents for both technical and non-technical audiences, adapting content to meet user needs and regulatory requirements Performs and/or supports internal and/or external audits as required Performs other related duties and projects as business needs require at direction of management Perform records management duties as needed Perform data collection and analysis to create and maintain quality metrics for review, identification, and escalation of document and records control trends and areas of improvement. Your expertise: Bachelor's degree in Life Sciences, Engineering, English, Technical Writing, or related field 2+ years of experience in technical writing within a regulated industry (preferably medical devices, pharmaceuticals, or biotech) Familiarity with Medical Device and IVD regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR) Solid knowledge of regulated and GMP document control lifecycle (approval, versioning, distribution, archiving, obsolescence) Exceptional written, proofreading, organizational and verbal communication skills with acute attention to detail Strong communication and interpersonal skills, with the ability to collaborate across multiple departments Ability to multitask and manage multiple priorities in a fast-paced environment Proficiency with MS Office (Word, Teams, Visio, Excel, PowerPoint), Adobe Experience with Electronic Quality Management Systems a plus This position is a 5 day a week, in-office position located at our Newark, DE, site. We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.