Pre-Analytical Laboratory Manager
Exact Sciences
full-time
Posted on:
Location Type: Office
Location: Redwood City • California • United States
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Salary
💰 $105,000 - $150,000 per year
About the role
- Oversee the operations of PreventionGenetics’ Pre-Analytical department
- Ensure all pre-analytical systems are functioning properly
- Conduct all quality-related activities as specified in the Quality Management System
- Serve as a liaison between Pre-Analytics and various functional groups
- Participate in cross-functional teams that improve the infrastructure, workflow and processes
- Consult with Quality and provide guidance to address non-conformances, complaints and CAPAs within the Pre-Analytical department
- Manage the operations of the Pre-Analytical Department including anticipating, planning for, and acquiring required staffing, equipment, space, and workflow improvements
- Lead and maintain the engagement of staff and project team members
- Ensure consistent compliance with all applicable federal, state, local and international regulatory requirements
- Contribute to inspection preparation efforts with Quality and various support teams.
Requirements
- Doctoral degree in clinical laboratory science, chemical, or biological science with 2 year training and experience in the respective specialty; OR Master's degree in medical technology, clinical laboratory science, or chemical, or biological science and 4 years training and experience in high-complexity testing in the respective specialty; OR Bachelor's degree in medical technology, clinical laboratory science, or chemical, or biological science and 6 years training and experience in high-complexity testing in the respective specialty.
- 8+ years of relevant experience which may include: 8+ years in a regulated environment such as manufacturing, clinical laboratory pre-analytical sample processing, biobanking, biomedical material processing, or equivalent.
- 5+ years of experiences in leading process or quality improvement projects, allocating resources and prioritizing key deliverables to optimize delivery timelines while meeting all critical requirements.
- 5+ years of management experience with a proven track record of implementing changes, scaling operations for growth, staff development, and building successful teams.
- General knowledge and understanding of CAP, GLP, GDP, CLIA, New York Department of Health (NYDOH) and HIPAA.
- Knowledge of Microsoft Office Suite tools, quality, and document control systems.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
Benefits
- paid time off (including days for vacation, holidays, volunteering, and personal time)
- paid leave for parents and caregivers
- a retirement savings plan
- wellness support
- health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical laboratory sciencemedical technologyhigh-complexity testingquality improvementprocess improvementstaff developmentresource allocationregulatory compliancedocument control systemsbiomedical material processing
Soft Skills
leadershipteam buildingcommunicationproject managementproblem-solvingstaff engagementcross-functional collaborationplanningprioritizationadaptability