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Labcorp has a Quality Assurance Auditor -Molecular BioA position at 671 South Meridan Road, Greenfield, IN. Work Schedule: Monday -Friday, 8am – 5pm. The Molecular department specializes in the development, validation, and execution of molecular techniques such as qPCR, RT-qPCR, and Digital PCR, supporting Cell Therapies, Gene Therapies, and Vaccines. We collaborate closely with clients to advance medicinal products through the drug development process. The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing study protocol, report/data and in-lab phase audits where applicable for multiple business areas. The auditor leads internal and external facility/process and/or supplemental inspections, provides recommendations for improving compliance, and prepares and delivers training in performance of audits.
Job Responsibility:
Conduct inspections in support of GLP or GCP method validation, study-based data and reports
Interpret and apply current policies, procedures and industry guidance in day-to-day auditing
Lead internal study in lab and process/facility inspections
Evaluate and follow up on inspection responses to ensure resolution
Collaborate on quality metrics and identify trends across departments
Review and provide consultation on controlled document revisions
Deliver training related to audit performance
Collaborate with QA teams across sites and contribute to local quality initiatives
Assist in the creation or revision of QA SOPs based on findings and continuous improvement efforts
Organize and manage the workload to meet business needs
Ensure compliance with GCP and GLP, and other applicable regulations
Perform other duties as assigned by management
Requirements:
Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
3 years in a regulatory environment (experience in GLC/GCP roles)
1 year experience in Molecular BioA
Knowledge of GLP/GCP auditing
Experience with Molecular department specializes in the development, validation, and execution of molecular techniques such as qPCR, RT-qPCR, and Digital PCR, supporting Cell Therapies, Gene Therapies, and Vaccines
Able to influence QA strategy
Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
Experienced in process improvement
Demonstrated ability to apply critical thinking skills
Clear communication skills, including ability to provide clear feedback
Able to clearly articulate processes to provide training
Able to influence process improvement initiatives and offer solutions