Quality Global LIMS Administrator

CSL•Holly Springs, NC

13d•Onsite

About The Position

The Quality Global LIMS Administrator 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), which supports product testing and laboratory data review. The role covers document management, application of global quality policies and standards, change controls, and deviation and corrective and preventive action (CAPA) review and administration. It provides technical support for cGMP compliance and helps ensure that the LIMS meets applicable legal, regulatory, and Seqirus Quality Manual requirements. The administrator serves as a global subject matter expert for the Global LIMS System. The role administers approved LIMS changes, provides local and global SME guidance, supports investigations and CAPAs, compiles metrics for senior management, trains users in applicable LIMS roles, and supports audit preparation. It works with local and global developers and business stakeholders to analyze metadata and trends, identify issues, recommend laboratory-testing improvements, and implement technical solutions. The administrator also leads global implementation of electronic system changes and supports change management, testing, validation, and ongoing system improvement initiatives.

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

Manage Global LIMS (GLIMS) processes.
Administer approved changes to the LIMS system as necessary.
Provide subject matter expert guidance locally and globally.
Comply with policies and procedures to maintain compliance with legal, health and safety, and regulatory requirements.
Participate in applicable deviation investigations as the LIMS liaison, ensuring complete and timely resolution and closure.
Compile relevant metrics for Senior Management review.
Attend project-related meetings as departmental representation when required.
Train users on applicable LIMS system roles to support manufacturing, technical development, and quality activities.
Participate in team meetings.
Support site and functional audit preparations related to LIMS functionality.
Interface with local and global developers to improve system functionality; analyze metadata and trends, make recommendations about laboratory testing, identify issues, and work with the business on technical solutions.
Lead global implementation of electronic system changes.
Lead project delivery and support the Change Management team in preparing and reviewing stakeholder analyses, role mappings, Change Impact Assessments, and job impact assessments where appropriate.
Participate in testing and validation of data and test scripts for functional-area processes, including integrated systems testing, operational qualification (OQ), user acceptance testing, and defect management.
Interface with other Seqirus and CSL Quality functions to share best practices and identify opportunities across Quality systems and processes.
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 system-related change controls.