Position Details
Qla Iii Microbial Investigations Apply
- Lead investigations into microbial excursions (e.g., surfaces, air, water, bioburden, endotoxin testing results) and determine scope, product impact, root cause, and corrective/preventive actions.
- Identify and implement immediate mitigation actions for microbial out-of-limits events.
- Assemble and lead cross-functional teams to complete investigations and drive process improvements through CAPA projects.
- Ensure timely closure of investigations to meet business and compliance needs.
- Collaborate with Subject Matter Experts (SMEs) and Quality Approvers to determine the investigation scope, identify root cause(s), and implement corrective/preventive actions.
- Manage investigation and CAPA documentation in TrackWise, ensuring compliance with internal practices and procedures.
- Present and defend investigation results during regulatory inspections as required.
- Education: Bachelor's or Master's degree in Microbiology or a related field.
- Experience:
- Minimum of 5+ years in Quality Operations, Microbiology Laboratory, and/or Quality within the pharmaceutical or medical device industry.
- 2+ years of experience in conducting root cause investigations.
- Strong understanding of pharmaceutical/medical device manufacturing, GMP, and Good Documentation Practices (GDP).
- Experience with problem-solving methodologies such as DMAIC.
- Excellent technical writing skills with the ability to translate complex findings into understandable documents.
- Strong communication and project management skills with the ability to influence various levels of the organization.
- Knowledge of FDA quality systems regulations.
- Working knowledge of TrackWise or other CAPA/investigation systems.
- Ability to work with minimal supervision and drive investigations to closure.
- Collaborative approach to problem-solving and driving process improvements.
- Strong analytical and troubleshooting skills.
