QA Associate III - Microbial Investigations
Location: NC
Contract Duration: 6 Months (Potential Extension)
We are looking for a skilled QA Associate III to lead microbial out-of-limits investigations. In this role, you will conduct root cause analyses, determine product impact, and implement corrective and preventive actions to address microbial excursions across surfaces, air, water, and other controlled environments. You’ll work closely with Quality, Operations, Engineering, Maintenance, and Supply Chain teams to ensure timely and effective investigation resolutions.
Primary Responsibilities:
- Lead investigations into microbial out-of-limits events, determining root causes and effective corrective actions.
- Identify and implement preventive actions in collaboration with cross-functional teams.
- Manage and document investigations and CAPA in TrackWise, ensuring regulatory compliance.
- Present and defend investigations during regulatory inspections as required.
Qualifications:
- Bachelor’s or Master’s degree in Microbiology or related field, with at least 2+ years in root cause investigations within the pharmaceutical or medical device industry.
- Minimum of 3-5 years in Quality Operations, Microbiology, or a related area.
- Proficiency in GMP, FDA quality systems regulations, and TrackWise.
- Strong technical writing, analysis, and project management skills.
