Laboratory Manager
AXIS CLINICALS LLC
Summary
The General Lab Supervisor is responsible for the intake, management, and testing of samples related to Axis Testing. They will be expected to maintain the standards, practices, and documentation necessary for working in a Clinical Laboratory Improvement Amendments (CLIA) regulated environment.
Job description
Summary
The General Lab Supervisor is responsible for the intake, management, and testing of samples related to Axis Testing. They will be expected to maintain the standards, practices, and documentation necessary for working in a Clinical Laboratory Improvement Amendments (CLIA) regulated environment.
Essential Functions
- Oversee daily laboratory operations, workflow, staffing, and testing efficiency across hematology, chemistry, special chemistry, serology, urinalysis, urine drug screening, and coagulation.
- Supervise laboratory personnel, coordinate training, and ensure required competency assessments and personnel records are maintained.
- Monitor quality control, proficiency testing, calibration, calibration verification, equipment maintenance, and corrective action activities.
- Ensure compliance with CLIA requirements, laboratory policies, standard operating procedures (SOPs), and applicable regulatory standards.
- Maintain laboratory documentation, including QC records, maintenance logs, reagent records, training files, and quality assurance documentation.
- Coordinate reagent and supply inventory, lot-to-lot comparisons, equipment service, and vendor support.
- Oversee specimen handling, testing workflow, turnaround times, critical-value notification processes, and accurate result reporting.
- Coordinate SOP reviews, method verification and validation activities, and implementation of new instruments or testing methods.
- Monitor laboratory safety, infection control, and personnel adherence to established procedures.
- Identify operational and quality improvement opportunities, investigate errors, implement corrective actions, and communicate significant concerns to the Laboratory Director.
- Assist with regulatory inspections, audits, budgeting, and operational performance monitoring.
- Execute other duties as assigned.
Knowledge, Skills and Abilities
- Communication
- Managing Priorities/Deadlines
- Problem-Solving and Analytical Ability
- Adaptability
- Professionalism
- Planning and organizing skills
- Judgement
Requirements
- Associates degree in Clinical Laboratory Sciences or Medical Lab Technician
- Minimum of 2 years' experience in a clinical or industrial laboratory
- Preferred: Bachelor's Degree in medical technology, biology or related life science
- Preferred: American Society for Clinical Pathology (ASCP) certification
Company overview
AXIS Clinicals LLC is a full-service Contract Research Organization (CRO) headquartered in Hyderabad, India, with a significant global presence including operations in the United States, Mexico, and Thailand. Founded in 2004, the company has established itself as a vertically integrated clinical research organization specializing in Phase II-IV clinical trials. AXIS Clinicals offers comprehensive services including project management, site management, medical writing, data management, biostatistics, regulatory services, and laboratory capabilities for BA/BE and PK/PD studies. The company has successfully completed over 1,300 clinical studies, 300+ ANDA study completions, and secured 50+ product approvals from various regulatory agencies. With a workforce of approximately 492 employees, AXIS Clinicals maintains accreditation from DCGI & NABL in India and has been inspected by major global regulatory bodies including US-FDA, UK-MHRA, Brazil-ANVISA, and France-AFSSAPS. The organization operates with a focus on providing cost-effective, high-quality clinical research services to pharmaceutical and biotechnology sponsors while adhering to ICH and CDSCO-GCP & GLP guidelines.