Job Information
CTG Lab Investigation Lead in Marion, North Carolina
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!
About CTG
CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit www.ctg.com .
Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations.
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.