Lab Investigation Lead

Summary

Job DescriptionJob DescriptionOverviewCTG is seeking to fill a Lab Investigation Lead opening for our client in Marion, NC.Location: Marion, NCDuration: 6 months with possible extension Duties:Determine scope, product impact, root cause, and corrective/preventive actions for microbial excursions including surfaces, viable air, non-viable air, water, bioburden, and endotoxin testing results.Expedite identification of potential root causes and implement immediate mitigation actions.Assemble cross-functional teams, conduct interviews, and observe operations to complete investigations.Lead process improvement CAPA projects to ensure timely and effective closure of investigations.Foster collaborative relationships to focus on high-quality investigations and effective corrective actions.Manage and close investigations in compliance with business and regulatory requirements.Work with Subject Matter Experts and Quality Approvers to implement CAPAs.Maintain investigation and CAPA documentation in TrackWise, ensuring compliance with established practices.Present and defend investigations during regulatory inspections, as required.Skills:Strong communication and project management skills.Excellent analysis, troubleshooting, and investigation skills, with knowledge of problem-solving methodologies (e.g., DMAIC).Strong technical writing skills to convey complex ideas clearly.Ability to interact and influence stakeholders at various organizational levels.Experience:2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry.Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality roles.Must have knowledge of FDA quality systems regulationsMust have working knowledge of TrackWise systemMust have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices.Education:Bachelor's or Master's degree in Microbiology or a related field.Excellent verbal and written English communication skills and the ability to interact professionally with a diverse group are required.CTG does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services for this role.To Apply: To be considered, please apply directly to this requisition using the link provided. For additional information, please contact Recruiter Laura Dominguez at laura.dominguez@ctg.com. Kindly forward this to any other interested parties. Thank you!

Job Description

Job DescriptionJob DescriptionOverviewCTG is seeking to fill a Lab Investigation Lead opening for our client in Marion, NC.Location: Marion, NCDuration: 6 months with possible extension Duties:Determine scope, product impact, root cause, and corrective/preventive actions for microbial excursions including surfaces, viable air, non-viable air, water, bioburden, and endotoxin testing results.Expedite identification of potential root causes and implement immediate mitigation actions.Assemble cross-functional teams, conduct interviews, and observe operations to complete investigations.Lead process improvement CAPA projects to ensure timely and effective closure of investigations.Foster collaborative relationships to focus on high-quality investigations and effective corrective actions.Manage and close investigations in compliance with business and regulatory requirements.Work with Subject Matter Experts and Quality Approvers to implement CAPAs.Maintain investigation and CAPA documentation in TrackWise, ensuring compliance with established practices.Present and defend investigations during regulatory inspections, as required.Skills:Strong communication and project management skills.Excellent analysis, troubleshooting, and investigation skills, with knowledge of problem-solving methodologies (e.g., DMAIC).Strong technical writing skills to convey complex ideas clearly.Ability to interact and influence stakeholders at various organizational levels.Experience:2+ years of experience in conducting root cause investigations in the pharmaceutical/medical products industry.Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality roles.Must have knowledge of FDA quality systems regulationsMust have working knowledge of TrackWise systemMust have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices.Education:Bachelor's or Master's degree in Microbiology or a related field.Excellent verbal and written English communication skills and the ability to interact professionally with a diverse group are required.CTG does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services for this role.To Apply: To be considered, please apply directly to this requisition using the link provided. For additional information, please contact Recruiter Laura Dominguez at laura.dominguez@ctg.com. Kindly forward this to any other interested parties. Thank you!