Quality Assurance Auditor - Molecular BioA

Labcorp • Greenfield, IN

8d • Onsite

About The Position

Labcorp’s Greenfield, IN site, is currently recruiting a Quality Auditor to support our Molecular Bioanalysis team. This role is ideal for candidates with at least 3 years of experience in a regulatory environment and/or Molecular Bioanalysis . 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. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role.

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

Nice To Haves

• 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

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 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.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees