Laboratory Manager

CorDx; Atlanta (GA); On-site; USD 70,000 - 132,000; Full time

Job summary

An established industry player in healthcare diagnostics is seeking a Laboratory Manager to lead operations and ensure compliance with regulatory standards. This role involves overseeing laboratory workflows, developing SOPs, and managing resources while fostering a collaborative team environment. The ideal candidate will have significant laboratory experience, a strong background in quality assurance, and a commitment to innovation. Join a dynamic team dedicated to delivering high-quality diagnostic solutions and enjoy comprehensive benefits including health insurance and a 401(k) plan.

Benefits

Comprehensive health insurance

401(k) plan with company match

Paid time off

Opportunities for professional development

Qualifications

• 5-10 years of laboratory experience in supervisory roles.
• Familiarity with ISO 13485, FDA regulations, and CAPA processes.

Responsibilities

• Supervise daily laboratory operations for efficient workflow.
• Ensure compliance with health and safety regulations.
• Develop training programs for laboratory techniques.

Skills

Laboratory Management

Standard Operating Procedures (SOPs)

Quality Assurance

ISO 13485

Good Laboratory Practices (GLP)

Lean Lab Methodologies

Education

Bachelor's Degree in Biology

Master's Degree in Biotechnology

Job description

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About Us
CorDx is a leading healthcare diagnostic manufacturer dedicated to delivering high-quality diagnostic solutions to consumers and healthcare professionals. Our commitment to innovation and excellence drives us to improve our products and services.

Responsibilities

• Supervise daily laboratory operations to ensure smooth and efficient workflow
• Develop, implement, and maintain Standard Operating Procedures (SOPs) for laboratory activities
• Plan and coordinate testing schedules, sample processing, and product validation activities
• Ensure proper documentation and data recording in line with Good Laboratory Practices (GLP) and regulatory requirements
• Manage lab resources, including equipment, reagents, and consumables, to support uninterrupted operations

Compliance & Quality Assurance

• Ensure laboratory operations comply with ISO 13485, FDA 21 CFR Part 820, GLP, and other applicable regulations
• Collaborate with the Quality Assurance team to implement quality control measures
• Participate in internal and external audits, inspections, and regulatory submissions
• Support the investigation of non-conformities and implementation of Corrective and Preventive Actions (CAPA)

Equipment & Inventory Management

• Oversee the maintenance, calibration, and qualification of laboratory equipment
• Manage laboratory inventory, including ordering supplies and monitoring stock levels
• Coordinate with vendors for equipment servicing and repairs

Team Leadership & Training

• Develop and deliver training programs for laboratory techniques, equipment operation, and safety protocols
• Conduct performance evaluations and provide mentorship to team members
• Foster a collaborative work environment and promote continuous improvement

Health, Safety & Risk Management

• Ensure compliance with health, safety, and biosafety regulations
• Develop and enforce laboratory safety protocols
• Organize regular safety training for laboratory personnel and conduct risk assessments and safety audits

Process Improvement & Innovation

• Identify opportunities to improve laboratory workflows and optimize resource utilization
• Implement Lean Lab and Continuous Improvement methodologies
• Collaborate with R&D and production teams on new product development, technology transfer, and scale-up activities

Requirements

• Bachelor's or Master's degree in Biology, Biotechnology, Molecular Biology, Biochemistry, or related field
• 5-10 years of laboratory experience, with at least 2-3 years in a supervisory or managerial role
• Experience in IVD, biotech, diagnostics, or medical device industries preferred
• Familiarity with ISO 13485, FDA, GLP, and CAPA processes

Benefits

• Comprehensive health insurance
• 401(k) plan with company match
• Paid time off and holiday schedule
• Opportunities for professional development and career advancement

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• IT Services and IT Consulting

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