Quality Assurance Auditor - Molecular BioA

Labcorp invites applications for a Quality Assurance Auditor – Molecular BioA at 671 South Meridan Road, Greenfield, IN. Work schedule is Monday through Friday, 8am to 5pm. Responsibilities 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 inspections in the lab and for 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. Verify 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. Lead internal and external facility/process and/or supplemental inspections, provide recommendations for improving compliance, and prepare and deliver training in performance of audits. Minimum Qualifications Bachelor’s Degree in Life Sciences (preferred) or equivalent Life Science experience. Three years in a regulatory environment (experience in GLC/GCP roles). One year experience in Molecular BioA. Preferred Qualifications Knowledge of GLP/GCP auditing. Experience with a Molecular department specializing in the development, validation, and execution of molecular techniques such as qPCR, RT‑qPCR, and Digital PCR, supporting Cell Therapies, Gene Therapies, and Vaccines. Ability to influence QA strategy. Knowledge of industry quality systems/standards and ability to apply applicable regulations to monitor compliance. Experience in process improvement. Demonstrated ability to apply critical thinking skills. Clear communication skills, including ability to provide clear feedback. Capability to articulate processes for training. Ability to influence process improvement initiatives and offer solutions. Benefits Full‑time employees (20 or more hours per week) are eligible for comprehensive benefits: Medical, Dental, Vision Life, STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement Employee Stock Purchase Plan Part‑time employees (less than 20 hours per week) are eligible to participate in the 401(k) Plan only. Equal Opportunity Employer Labcorp is a proud Equal Opportunity Employer. Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. #J-18808-Ljbffr LAB Labcorp Early Development Laboratories Inc.