| Senior Specialist, Quality Systems at Remote, Remote, USA |
| Email: [email protected] |
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https://jobs.nvoids.com/job_details.jsp?id=2092597&uid= From: Anju Pathak, Tek Inspirations LLC [email protected] Reply to: [email protected] Job Description - Senior Specialist, Quality Systems (REMOTE ROLE ) 6+ months Domain - Pharma CITIZEN,GREEN CARD Prefer local candidates in Emeryville, CA Senior Specialist, Quality Systems Job description Position Summary We are seeking a Senior Specialist, Quality Systems to provide quality expertise to support our Qualitys team for the development and commercialization of products in compliance with relevant US, EU and ICH requirements. The Sr Specialist, Quality Systems role will support in the execution, development, and continuous improvement of the Document Control/Management and Training Program as we grow and mature organizationally. We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (eQMS), and to implement process improvements to meet business and regulatory requirements. Responsibilities Supports the day-to-day management of the Quality Systems department, including areas such as Document Control and Training. Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides. Maintain internal formatting standards and ensure all documentation is formatted accordingly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Assist with the Quality training program including collaborating with department managers to develop training requirements and training plans. Create and maintain GxP training files and matrices. Participate in system validation activities, as required. Generate compliance metrics and prepare routine KPI reports. Assists in delivery, maintenance, and continuous improvement of GxP processes in eDMS, eLMS, and eQMS. Adhere to all cGMPs, compliance/regulatory mandates and quality requirements. Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality. Perform other duties, as assigned. Bachelors degree in Computer Science, Life Science or related field or applicable experience. 4+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry. Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures. Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired. Experience with Dot Compliance, preferred. Experience developing improvements to electronic Quality Systems. Strong software proficiency with Microsoft Suite and other desktop applications. Ability to manage multiple projects in a dynamic environment with attention to detail. A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties. Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Qualifications Bachelors degree in Computer Science, Life Science or related field or applicable experience. 4+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry. Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures. Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired. Experience with Dot Compliance, preferred. Experience developing improvements to electronic Quality Systems. Strong software proficiency with Microsoft Suite and other desktop applications. Ability to manage multiple projects in a dynamic environment with attention to detail. A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties. Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Keywords: California Senior Specialist, Quality Systems [email protected] https://jobs.nvoids.com/job_details.jsp?id=2092597&uid= |
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| 02:05 AM 18-Jan-25 |