Quality Global LIMS Administrator
About The Position
Supports development and maintenance of global quality system processes, procedures, and operational activities for Quality oversight of the Laboratory Information Management System (LIMS), including product testing and laboratory data review, document management, application of global quality policies and standards, change controls, and deviation/CAPA review and administration. Provides technical support for LIMS-related cGMP compliance, ensuring compliance with cGMPs, legal and regulatory requirements, and the Seqirus Quality Manual. Serves as a global subject matter expert for the Global LIMS system and provides local and global guidance. The role administers approved LIMS changes, supports deviation investigations and CAPAs, compiles metrics for senior management, attends project meetings, delivers role-specific LIMS training, and supports audit preparation. It works with local and global developers to improve system functionality, including analysis of metadata and trends and recommendations for laboratory testing. The role leads global implementation of electronic system changes and supports change-management activities, including stakeholder analysis, role mapping, change impact assessments, and job impact assessments. The administrator participates in testing and validation of data and test scripts, including integrated systems testing, operational qualification, user acceptance testing, and defect management. The role collaborates with Seqirus and CSL Quality functions to share best practices, support GLIMS alignment, and improve business processes. Qualifications listed are a bachelor’s degree in Engineering, Business, or a relevant scientific discipline; 4–8 years of laboratory experience; and 3–5 years of quality systems experience in pharmaceutical manufacturing or a cGMP-regulated environment. Experience with electronic document management systems, specifically LIMS, is preferred. Different qualifications or responsibilities may apply based on local legal or educational requirements; refer to local job documentation where applicable.
Requirements
- Bachelor’s degree in Engineering, Business, or a relevant scientific discipline such as Chemistry, Biology, or Microbiology.
- 4–8 years of laboratory experience.
- 3–5 years of quality systems experience in pharmaceutical manufacturing or a cGMP-regulated environment.
Nice To Haves
- Experience with electronic management systems for documents, specifically LIMS.
Responsibilities
- Support development and maintenance of global quality system processes, procedures, and operational activities related to Quality oversight of LIMS.
- Administer approved changes to the LIMS system.
- Provide local and global subject matter expertise and guidance for the Global LIMS system.
- Maintain compliance with applicable policies, procedures, legal regulations, health and safety requirements, regulatory requirements, cGMPs, and the Seqirus Quality Manual.
- Participate in deviation investigations as a LIMS liaison to ensure timely and complete resolution and closure.
- Compile relevant metrics for senior management review.
- Attend project-related meetings as departmental representation when required.
- Train applicable LIMS system roles supporting manufacturing, technical development, and Quality activities.
- Participate in team meetings.
- Support site and functional audit preparation related to LIMS functionality.
- Interface with local and global developers to improve system functionality.
- Analyze metadata and review trends to make recommendations to the business regarding laboratory testing; identify issues and develop technical solutions with the business.
- Lead global implementation of electronic system changes.
- Lead project delivery and support change-management preparation and review, including stakeholder analysis, role mapping, change impact assessments, and job impact assessments where appropriate.
- Participate in testing and validation of data and test scripts, including integrated systems testing, operational qualification, user acceptance testing, and defect management.
- Share best practices and identify opportunities across Seqirus and CSL Quality functions and systems.
- Assist in driving GLIMS alignment across the organization.
- Participate in system-improvement initiatives to optimize GLIMS business processes and practices.
- Support deviation investigations and own CAPAs related to systems.
- Support evaluations of change controls related to systems.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
