About the role: You will help maintain the LIMS, Empower and other QC systems, per 21 CFR requirements, including daily maintenance, account management, troubleshooting and training. Additionally, you will provide quality support relative to computer systems on site, including risk assessments, qualification documentation, data integrity, change control assessments, investigations, deviations, CAPA and periodic review of computer system validations. You will report to the QA Computer System Administrator Manager in Social Circle, GA. How you will contribute: Administer all datagroups, users and permissions within the LIMS, Empower and other QC system. Support troubleshooting of cross instance configuration from other sites in the network and inbound and outbound LIMS communication with EBM systems. Review and update software operational and administrative SOP's. Provide and conduct training on LIMS. Involve in activities related to new instruments that will be installed and will be communicated with LIMS and Empower. Support on validation's and related documentation for new functionality and upgrades to any computer systems including LIMS at the site. Maintain data integrity, including performing assessments, periodic reviews and disaster recovery per FDA guidelines and company SOP's. Assist analysts in troubleshooting issues via remote connection after business hours. Monitoring/Control of the SQL LIMS Database, and other QC instruments. Provide technical subject matter expert (SME) support for authoring and reviewing Data Integrity Assessments, Risk Assessments, and Remediation Plans. Provide regulatory and internal compliance guidance for computer systems commissioning, qualification and validation activities. Review and approve computer system related validation documents and quality system records such as deviations, CAPA, and change control. Participate on teams to determine the root cause and corrective actions for problems associated with investigations. Perform, support and review periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the systems. Establish and enhance the relationships between IT, Automation, Validation, manufacturing units through collaboration, respectful challenge, and ability to support QA decisions. Participate in audits and regulatory agency inspections as a representative of QA Systems. Excellent analytical skills with systematic approaches to problem solving. Will break down complex problems and tasks into manageable activities. Knowledge in basic principles in automation and computer systems. Identify when proper practices/ procedures are not performed. Be a support function to site operations and is required to coordinate activities and communication with IG, Fractionation, and Albumin. Also, you will also correspond with other support departments such as QA, EBM, Engineering, Maintenance. You should work with different disciplines in Takeda to support data integrity, commissioning and qualification activities for any computer systems. You may participate in interdepartmental teams and communicate with different levels of personnel including management, site leadership and global.

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