QA Auditor - GLP/GCP

Labcorp • Indianapolis, IN

9h • Onsite

About The Position

QA Auditor in Indianapolis, IN. Schedule: Monday – Friday 8-5 pm Job Responsibilities: Conduct, but not limited to protocol review, where applicable for specific study types lead internal facility/process inspections Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution Report on relevant quality metrics (for multiple topics/departments) and highlight trends Provide consultation to the operational team (e.g. as they revise/write controlled documents) Delivery of training in performance of audits Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills] Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization Create and/or re-write QA SOPs based on findings from local quality initiatives. Organizing, Prioritizing and Managing all aspects of workload to meet business needs Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and where applicable for specific study types participate in internal facility/process and/or supplemental inspections, initiates, and reviews SOPs 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), and Good Laboratory Practice (GLP) in the performance of their role Labcorp is recognized as one of the world’s best employers and named as one of the most innovative companies. At Labcorp, you will find a rewarding role that allows you to make a difference in people’s lives, including your own! Join an exceptional organization and an exceptional Quality department.

Requirements

• Minimum: Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
• Experience may be substituted for education
• 3 years in a regulatory environment
• Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
• Experienced GLP/GCP auditor
• 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

Nice To Haves

• Knowledge of auditing and techniques to monitor compliance
• Experience in a Laboratory (GLP/GCP)

Responsibilities

• Conduct, but not limited to protocol review, where applicable for specific study types lead internal facility/process inspections
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
• Report on relevant quality metrics (for multiple topics/departments) and highlight trends
• Provide consultation to the operational team (e.g. as they revise/write controlled documents)
• Delivery of training in performance of audits
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
• Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization
• Create and/or re-write QA SOPs based on findings from local quality initiatives.
• Organizing, Prioritizing and Managing all aspects of workload to meet business needs
• Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
• The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and where applicable for specific study types participate in internal facility/process and/or supplemental inspections, initiates, and reviews SOPs and prepares and delivers training in performance of audits.

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