Novartis
GCP Bioanalysis Lab Operations Expert
This job is now closed
Job Description
- Req#: 393621BR
Onsite
About the role:
As a Good Clinical Practice (GCP) Bioanalytical Lab Operations Expert, you will be responsible for the equipment and sample management operations of a bioanalytical laboratory that adheres to GCP guidelines. Your role will involve ensuring the highest standards of quality and compliance in the laboratory's operations, leading a team of sample managers, and effectively communicating with internal and external stakeholders.
Your key responsibilities:
• Instrument fleet management: Oversee preventative maintenance/repairs and software updates in compliance with SOPs and regulatory requirements, and maintain logbooks in accordance with GCP standards. Write/edit/review SOPs for general instrument usage and maintenance.
• Asset management: responsible for purchasing CAPEX and low-value assets, in close collaboration with the lab scientists, facilities, and finance teams.
• Sample management: Lead a team of sample managers, supervising the proper handling, labeling, storage, and disposal of clinical trial samples according to GCP guidelines, SOPs, and protocol requirements. Ensure the integrity and chain of custody of samples throughout their lifecycle.
• Data Management: Implement data management systems and ensure that data is properly recorded, stored, and backed up.
• Computerized System Validation and Management: Development and implementation of validation plan for computerized systems used in the bioanalytical lab, ensuring compliance with GCP guidelines and regulatory requirements, and managing system installation, configuration, training, data integrity, security, and system updates.
• Continual improvement: ongoing evaluation and improvement of laboratory processes, workflows, and efficiencies related to sample management and equipment operations. Implement automation and technology solutions to enhance productivity and data quality. Stay updated with industry trends, regulations, and advancements in bioanalytical sciences.
• Collaboration and communication: Collaborate with cross-functional teams, including lab staff, vendors, facilities, reconciliation specialists, and archivists to support bioanalytical activities in clinical trials. Communicate effectively with internal and external stakeholders. Foster a culture of collaboration, operational excellence, and continuous improvement within the team.About the company
At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...
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