Responsibilities:

1. Conduct minor, major, and critical investigations related to site exceptions and deviations.
2. Perform Phase II OOS investigations and support root cause analysis activities.
3. Identify root cause and develop appropriate corrective and preventive actions (CAPA).
4. Trend quality metrics including KPIs, Cost of Poor Quality, and quality management review data.
5. Support regulatory inspections and external audits (documentation support, scribing, document preparation).
6. Assist with data compilation for Annual Product Reviews (APRs).
7. Revise and update SOPs to maintain compliance with GMP and regulatory requirements.
8. Prepare GEMBA plans and perform walkthroughs to drive compliance and safety improvements.
9. Track assignments to completion and report investigation progress to management.
10. Collaborate cross-functionally with Operations, Engineering, Materials, and Quality teams.

Requirements:

1. Bachelor’s degree in Chemistry, Microbiology, Biology, Engineering, or related science (or equivalent experience).
2. 3–5+ years of experience in a pharmaceutical, biotech, or other FDA-regulated GMP environment.
3. Hands-on experience conducting deviation investigations and OOS investigations.
4. Strong understanding of cGMPs, FDA regulations, and quality systems.
5. Experience writing investigation reports and supporting CAPA implementation.
6. Proficiency in SAP and Microsoft Office (Word, Excel, Outlook).
7. Strong documentation practices and attention to detail.
8. Ability to work independently while collaborating across departments.