Quality Assurance Auditor Molecular BioA
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Job Location:
Greenfield, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Labcorp has a Quality Assurance Auditor -Molecular BioA position at 671 South Meridan Road Greenfield IN.
Work Schedule: Monday -Friday 8am 5pm
Job Responsibilities:
Conduct inspections in support of GLP or GCP method validation study-based data and reports
Interpret and apply current policies procedures and industry guidance in day-to-day auditing
Lead internal study in lab and process/facility inspections
Evaluate and follow up on inspection responses to ensure resolution.
Collaborate on quality metrics and identify trends across departments.
Review and provide consultation on controlled document revisions.
Deliver training related to audit performance.
Collaborate with QA teams across sites and contribute to local quality initiatives.
Assist in the creation or revision of QA SOPs based on findings and continuous improvement efforts.
Organize and manage the workload to meet business needs.
Ensure compliance with GCP and GLP and other applicable regulations.
Perform other duties as assigned by management.
Minimum Qualifications:
Bachelors Degree in Life Sciences preferred (or equivalent Life Science experience)
3 years in a regulatory environment (experience in GLC/GCP roles)
1 year experience in Molecular BioA
Additional Qualifications:
Knowledge of GLP/GCP auditing
Experience with Molecular department specializes in the development validation and execution of molecular techniques such asqPCR RT-qPCR and Digital PCR supportingCell Therapies Gene Therapies and Vaccines.
Able to influence QA strategy
Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance
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
Labcorps Greenfield IN site is currently recruiting aQuality Auditorto support ourMolecular Bioanalysisteam. This role is ideal for candidates with at least3 years of experience in a regulatory environmentand/orMolecular Bioanalysis.
The Molecular department specializes in the development validation and execution of molecular techniques such asqPCR RT-qPCR and Digital PCR supportingCell Therapies Gene Therapies and Vaccines. We collaborate closely with clients to advance medicinal products through the drug development process.
The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing study protocol report/data and in-lab phase audits where applicable for multiple business areas. The auditor leads internal and external facility/process and/or supplemental inspections provides recommendations for improving compliance 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) Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) in the performance of their role.
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 PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible toparticipatein the 401(k) Plan only. 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.
We encourage all to apply
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Required Experience:
IC
Key Skills
About Company
Labcorp helps patients, providers, organizations, and biopharma companies to guide vital healthcare decisions each and every day.
