Job Profile Summary
- Responsible for laboratory testing in accordance with applicable regulations governing clinical laboratories.
- Performs a wide variety of testing to produce accurate, reliable, and reproducible data to support clinical trials research; and ensures accurate and timely reporting of results.
Responsibilities
- Responsible for supervising a team of lab staff and ensuring effective operational delivery.
- Responsible for setting day to day operational activities for the team with a focus on daily delivery.
- Under the mentorship of management, responsible for hiring, training, and performance management of staff.
- Supervises the daily activities of assigned laboratory work group(s) through appropriate delegation, technical skills training, and work supervision. Meets regularly with staff and senior management to discuss and resolve workload and technical issues.
- Screens and assigns workload. Plans, prioritizes, and assigns tasks and projects.
- Responsible for monitoring of inventory of reagents and supplies to ensure adequate levels for deliverables. Ensures spend is within approved budgetary amount.
- Responsible for ensuring activity in the team meets safety guidelines. Drives individual accountability for safety across the team. Identifies opportunities for improvements in safety.
- Responsible for the review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
- Partners with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
- Independently identifies and evaluates vendor platforms to that may help meet goals of the initiatives.
- Determines resourcing needs to ensure effective delivery.
- May act as a backup in any area of daily laboratory operations.
- Responsible for ensuring operations meet quality guidelines.
- Ensures timely and appropriate resolution of CAPA and quality incidents, quality and compliance metrics, root cause analysis and improvement.
- Ensures policies, practices and procedures are understood and followed by direct reports, customers, and stakeholders.
- Assists in establishment and revision of laboratory policies and procedures. Maintains appropriate control and quality assurance procedures. Ensures compliance with safety requirements.
- Keeps abreast of new technical developments. Assist with implementation of new tests, equipment, programs and/or procedures in the assigned area(s) as needed. Contribute to continuous improvement initiatives to increase quality of services and operational efficiency.
- Fosters a unified culture and facilitates collaboration, cooperation, sharing of information and teamwork. Participates in initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
- Manages staff in accordance with organization’s policies and applicable regulations.
- Supports safety, quality, and 6S requirements and initiatives.
- Complies with company's procedures and applicable regulatory requirements.
Criteria / Requirements
- Subject Matter Expert (solid knowledge in query management) in Auto-Chemistry
- At least 4 years of professional experience involving exposure and knowledge in Auto-Chemistry techniques / troubleshooting.
- Masters or PhD educational qualification (relevant science background) or Bachelor’s degree ideally with a combination of work experience / training.
- Prior line management duties will be advantageous although not mandatory.
- Working knowledge of quality assurance and quality control principles and in-depth knowledge of company-specific program requirements.
