Lab Investigation Lead

Overview

CTG is seeking to fill a Lab Investigation Lead opening for our client in Marion, NC.

Location: Marion, NC
Duration: 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 regulations
• Must have working knowledge of TrackWise system
• Must 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!