Quality Global LIMS Administrator

CSL Plasma; Holly Springs (NC); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

CSL Plasma is seeking a quality systems specialist to support the Laboratory Information Management System (LIMS) global oversight. You will participate in validation, deviation investigations, CAPA administration, and change controls to ensure cGMP compliance across sites.

The role requires a bachelor’s degree in a relevant field and 4–8 years of laboratory experience with quality systems experience in pharma manufacturing. Onsite work and global collaboration are essential.

Competenze

• 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.
• Refer to local job documentation where applicable.

Mansioni

• Supports development and maintenance of global quality system processes for LIMS oversight.
• Provides LIMS technical support ensuring cGMP compliance and regulatory requirements.
• Acts as global SME to support the Global LIMS System and manage GLIMS processes.
• Participates in deviations investigations and CAPA related to systems.
• Leads testing, validation, and change management activities for LIMS.
• Interfaces with local and global developers to improve system functionality.

Conoscenze

Laboratory experience

Quality systems

cGMP compliance

LIMS knowledge

Data analysis

Formazione

Bachelor degree in Engineering, Business or a relevant scientific discipline

Strumenti

LIMS software

Descrizione del lavoro

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 processesAdminister 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 testingOQ - Operational qualificationUser acceptance testingDefect managementInterface 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.#LI-Onsite

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.