Responsible for the operation, leadership, direction and administration of Lab Operations in accordance with applicable regulations governing clinical laboratories. Perform work in accordance with ICH E6 Guideline for Good Clinical Practice.
location: Morrisville, North Carolina
job type: Permanent
salary: $160,000 - 170,000 per year
work hours: 9 to 5
- Oversee the overall operations of the Lab Operations of the laboratory organization.
- Ensure that laboratory operations meet or exceed all applicable regulatory requirements.
- Responsible for overseeing multiple disciplines and/or functional areas.
- Ensure that the highest standards of quality and customer service are maintained.
- Collaborate with Quality Assurance staff on development and implementation of effective programs
- Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory
- Establish effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
- Ensure that laboratory staff are trained on and comply with safety procedures. Establish and implement procedures to ensure that the physical laboratory environment meet safety requirements
- Participate in the development and implementation of the department's operating budget
- Establish standards for cost control and waste reduction
- Monitor utilization patterns of services and advise on developing trends in clinical service needs
- Keep abreast of new technical developments
- Implement new tests, equipment, programs and/or procedures in the department as needed
- Lead continuous improvement initiatives to increase quality of services and operational efficiency
- Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork
- Manage staff in accordance with organization's policies and applicable regulations
- Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
- Approve actions on human resources matters.
- In depth knowledge of Lab Operations procedures and applicable laboratory testing regulations
- Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
- Knowledge of occupational safety and health rules and regulations
- Excellent written and oral communication skills
- Excellent client management and problem resolution skills
- Excellent financial management skills
- Effective mentoring and coaching skills
- High ethical standards
- Strong operational focus
- Ability to motivate a team to achieve shared goals within performance standards and budget
- Ability to assess and prioritize multiple tasks, projects and demands
- Ability to make effective and persuasive presentations on controversial or complex topics to clients, senior management and other stakeholders
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
skills: Chemistry, GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.