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Supports the development and maintenance of global quality system processes, procedures and operational activities related to Quality oversight of the Laboratory Information Management System (LIMS), associated with product testing and laboratory data review, which includes, but is not limited to, Document Management, Application of Global Quality Policies & Standards, Change Controls, and Deviation/Corrective and Preventative Action review and administration. Provides LIMS technical support in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements. Serves as global SME to support the Global LIMS System. Manage GLIMS processes Administer approved system changes to the LIMS system, as necessary. Provide SME guidance locally and globally. Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written. Participates in all applicable deviation investigations, serving as a LIMS liaison to ensure complete and timely resolution and closure. Compile pertinent metrics for Senior Management review. Attends project related meetings as departmental representation, as required. Performs training on applicable LIMS system roles to support manufacturing, technical development and quality activities. Actively participate in team meetings. Support site and function audit preparations with respect to LIMS functionality. Interface with local and global developers to improve system functionality. This includes manually analyzing meta data and reviewing trends to make recommendations to the business regarding laboratory testing. They are identifying issues and strategizing with the business to implement technical solutions. Lead project implementation of electronic system changes across the globe. Actively lead project delivery and support the Change Management team in the preparation and review of stakeholder analysis, role mapping, Change Impact Assessments and job impact assessments where appropriate. Participate in the testing and validation of the data & test scripts pertaining to the processes of the functional area including: Integrated systems testing OQ – Operational qualification User acceptance testing Defect management Interface with other Seqirus and CSL Quality functions to share best practices and identify / leverage opportunities across Quality systems and processes. Assist in driving GLIMS alignment across the organization. Participate in system improvement initiatives to optimize the business processes and practices within GLIMS. Support investigation of deviations and own CAPAs related to systems. Support evaluations of change controls related to systems. Qualifications: Bachelor degree in Engineering, Business or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.) 4-8 years of laboratory experience 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment Experience with electronic management systems for documents, specifically LIMs preferred. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. #LI-Onsite About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. Watch our ‘On the Front Line’ video to learn more about CSL Seqirus CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates
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Seqirus USA - NC - Holly Springs, United States of America