Location: all cities,NC, USA
**Job Title:** QA Associate III
**Location:** NC
**Duration:** 6-Month Contract (Possible Extension)
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### Overview
We are seeking a QA Associate III to take on the role of Microbial Out-of-Limits (MO) Investigator. This position involves leading investigations into microbial excursions within our operations, focusing on root cause analysis and the implementation of corrective actions. The ideal candidate will bring creativity and critical thinking to address challenges in a fast-paced environment. Flexibility in work hours is required, with typical first shift hours and occasional off-shift responsibilities.
### Responsibilities
- **Investigation Leadership**: Identify and analyze the scope, product impact, root cause, and corrective/preventive actions for microbial excursions (e.g., surfaces, viable/non-viable air, water).
- **Root Cause Analysis**: Rapidly determine potential root causes and implement immediate mitigation strategies.
- **Cross-Functional Collaboration**: Build and lead teams across departments, conduct interviews, and observe operations to drive investigations and process improvements.
- **Timely Closure**: Manage and document investigations in TrackWise, ensuring all actions are completed promptly to meet business and compliance needs.
- **Regulatory Engagement**: Present investigation findings during regulatory inspections as necessary.
- **Quality Improvement**: Foster collaborative relationships aimed at enhancing investigation quality and reducing the rate of out-of-limit occurrences.
### Qualifications
- **Education**: Bachelors or Masters degree in Microbiology or a related discipline.
- **Experience**: Minimum of 2 years in root cause investigations within the pharmaceutical/medical products industry and at least 5 years in Quality Operations, Microbiology Laboratory, or Quality roles.
- **Skills**:
- Strong communication and project management skills.
- Comprehensive understanding of pharmaceutical/medical device manufacturing, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
- Proficient in analysis, troubleshooting, and problem-solving methodologies (e.g., DMAIC).
- Excellent technical writing skills to articulate complex issues clearly.
- Ability to engage and influence personnel at various organizational levels.
- Familiarity with FDA quality systems regulations and TrackWise documentation.
### Additional Information
This role is vital to maintaining the safety and quality of products that serve patients globally. The successful candidate will be proactive, detail-oriented, and adept at managing multiple investigations while upholding the highest quality standards.