QA Auditor - BioA

LAB Labcorp Early Development Laboratories Inc.; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(k)

Paid Time Off (PTO) or Flexible Time

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp in Madison, WI seeks a Quality Auditor - BioA to verify SOP compliance and perform protocol, data, and in-lab phase audits for study types.

The role emphasizes regulatory compliance (GCP/GLP), QA SOP peer reviews, and reporting quality metrics, with a bachelor’s degree in life sciences preferred and experience in regulatory environments and LCMS/BioA.

Qualifications

• Bachelor’s Degree in Life Sciences preferred.
• Experience may be substituted for education.
• 2 years in regulatory environment (BioA and/or LCMS) preferred.
• 1 year experience BioA and LCMS.

Responsibilities

• Conduct protocol review and audits.
• Peer review QA SOPs.
• Support operational liaison meetings representing QA.
• Report on quality metrics and trends.
• Ensure regulatory compliance and QA responsibilities.
• Adhere to required timeline on activities.

Skills

Quality Assurance

Regulatory compliance

GXP knowledge

Data interpretation

Education

Bachelor's Degree in Life Sciences

Tools

HPLC

Mass spectrometry

LCMS

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.

Join our Labcorp Quality department as a Quality Auditor - BioA. Work Schedule: Monday Through Friday 8-5 pm in Madison, WI. The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and in-lab phase audits where applicable for specific study types, participate in internal facility/process and/or supplemental inspections, and peer review QA SOPs. 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.

Job Focus Areas:

• Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections
• Peer review QA SOPs
• Support operational liaison meetings representing QA function
• Report on relevant quality metrics (for single topics/departments) and highlight trends
• Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
• Other duties as assigned by management

Minimum Qualifications:

• A minimum of a Bachelor’s Degree in Life Sciences preferred
• Experience may be substituted for education.

Preferred Qualifications:

• 2 years in regulatory environment (experience in GXP roles) BioA and/or LCMS
• 1-year expereince BioA and LCMS

Additional Job Standards:

• Understanding of chromatography (i.e. HPLC)
• Experience with mass spectrometry/hybrid tandem mass spectrometry instrumentation
• Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor compliance
• Ability to interpret data and identify quality critical problems
• Able to convey regulatory expectations
• Support 'business partner' /liaison meetings representing QA function with operations (local)
• Report on relevant quality metrics (for single topics/departments) and highlight trends
• Adhere to required timeline on assigned activities
• Peer Review QA SOP's
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated

Why People choose to work at Labcorp?

At Labcorp, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to work with extraordinary people with diverse viewpoints. You’ll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond. We help our clients develop medicines that improve health and improve lives of their family and friends.

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.

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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We believe in the power of science to change lives.

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.

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