QA Auditor - BioA

About the role

Join Labcorp’s Quality department as a Quality Auditor - BioA in Madison, WI. In this role, you will verify compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and in-lab phase audits for specific study types. You will also participate in internal facility/process and/or supplemental inspections, and peer review QA SOPs. All employees are responsible for complying with applicable regulations such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

Responsibilities

• Conduct protocol reviews, report/data audits, and internal facility/process inspections
• Peer review QA SOPs
• Support operational liaison meetings representing the QA function
• Report on relevant quality metrics and highlight trends
• Ensure Regulatory Compliance and Quality Assurance responsibilities are followed as indicated in applicable controlled documents
• Interpret and apply regulations to monitor compliance
• Interpret data and identify quality-critical problems
• Convey regulatory expectations
• Adhere to required timelines on assigned activities
• Perform other duties as assigned by management

Requirements

• A minimum of a Bachelor’s Degree in Life Sciences (preferred) or equivalent experience
• 2 years in a regulatory environment (experience in GXP roles preferred)
• Experience with BioA and/or LCMS (1 year preferred)
• Understanding of chromatography (e.g., HPLC)
• Experience with mass spectrometry/hybrid tandem mass spectrometry instrumentation
• Ability to interpret and apply regulations to monitor compliance
• Ability to interpret data and identify quality-critical problems

Benefits

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits, including:

• Medical, Dental, and Vision coverage
• Life, Short-Term Disability (STD), and Long-Term Disability (LTD) insurance
• 401(k) retirement plan
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• Employee Stock Purchase Plan

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

Schedule

Monday through Friday, 8:00 AM – 5:00 PM in Madison, WI.