Quality Auditor - GLP/GCP

About the role

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN. The Quality Auditor plays a pivotal role as part of our Quality Assurance team in ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices, including GCP/GLP, ISO 15189, ISO 13485 and CAP.

Work Schedule

Monday Through Friday 8-5 pm

Responsibilities

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
• Contribute to global QA policies on interpretation/application of regulations
• Provide subject matter expertise to projects
• Support team in CAPA plan creation
• Host external audits/inspections e.g. regulatory inspections, strategic clients
• Assist with the facilitation of audit responses
• Support the QA–to-QA relationship with key client(s)
• Delivery of training in performance of audits (basic, intermediate, complex)
• Participate (for multi-regulatory topics in area of expertise) in global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
• Support the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

Qualifications

• Bachelor's Degree in Pharmacy, Chemistry or Biology related discipline
• 6 years in regulatory environment in GLP/GCP regulatory environment
• 2 years of Auditing experience

Preferred Qualifications

• Postgraduate degree (MSc or equivalent) in science or management related discipline
• Experience of industry quality systems/standards
• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

Additional Job Standards

• Ability to demonstrate effective communication verbally and written with an emphasis on strategic communication with clients
• Excellent organizational and project management abilities

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. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan.