QA Auditor - BioA

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: 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. For more detailed information, please click 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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