Job Description

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

Laboratory Operations & Management

• 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.

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