Quality Auditor - GLP/GCP

Labcorp; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(k)

PTO/FTO

Tuition Reimbursement

Employee Stock Purchase Plan

401(k) for part-time

Job summary

Labcorp in Indianapolis, IN is seeking a Quality Auditor to join our Quality Assurance team. The role focuses on ensuring clinical research laboratory operations comply with GLP/GCP, ISO 15189, ISO 13485 and CAP, and supports audits and regulatory inspections.

The ideal candidate holds a Bachelor's in a science field, plus 6 years in a regulatory GLP/GCP environment and 2 years of auditing, with postgraduate MSc or equivalent preferred.

Qualifications

• Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.
• 6 years in regulatory GLP/GCP environment.
• 2 years of Auditing experience.
• Postgraduate degree (MSC or equivalent) in science or management related discipline.

Responsibilities

• Conduct audits as identified on the audit activity table.
• Contributes to global QA policies on interpretation/ application of regulations.
• Provide subject matter expertise to projects; Support CAPA plan creation.
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients; Assists with the facilitation of audit responses.
• Supports the QA-to-QA relationship with key client(s).
• Delivery of training in performance of audits (basic, intermediate, complex).
• Participate in global Quality initiatives aimed at improving compliance/efficiency of the QA organization.
• Supports the reporting of quality metrics and implementation of corrective actions.

Skills

Regulatory compliance

Audit experience

GCP/GLP knowledge

Interpersonal skills

Documentation

Education

Bachelor’s Degree in Pharmacy, Chemistry or Biology

Postgraduate degree (MSC or equivalent) in science/management

Job description

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Labcorp is seeking a Quality Auditor, GLP/GCP to join our team in Indianapolis, IN

Work Schedule:

Monday Through Friday 8-5 pm

Job Responsibilities

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.

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
• Contributes to global QA policies on interpretation/ application of regulations
• Provide subject matter expertise to projects Support team in CAPA plan creation
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
• Supports 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) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
• Supports 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

Minimum Qualifications

• Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
• 6 years in regulatory environment in GLP/GCP regulatory environment.
• 2 years of Auditing experience
• Postgraduate degree (MSC or equivalent) in science or management related discipline

Preferred Qualifications

• 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.

At Labcorp, You Can Expect The Following

• Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.
• Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.

Benefits:

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(k)
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• 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.

For more detailed information, pleaseclick here.

Labcorp Is Proud To Be An Equal Opportunity Employer

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. 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.

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