Quality Assurance Auditor - Molecular BioA

Labcorp • Greenfield, IN

5d • Onsite

About The Position

Labcorp has a Quality Assurance Auditor -Molecular BioA position at 671 South Meridan Road, Greenfield, IN. Work Schedule: Monday -Friday, 8am – 5pm 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

• Minimum: 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
• 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, but not limited to protocol review, single department report/data audits, in-lab phase audits where applicable for multiple business areas
• Development and delivery of training to operational groups
• Delivery of training in performance of audits
• Provide advice and guidance on aspects of quality and compliance
• Provide consultation to the operational team on quality issue
• Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
• Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
• Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed

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