Quality Investigator

Accentuate Staffing; Raleigh (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading staffing agency is seeking a Quality Investigator for a pharmaceutical manufacturing company in Raleigh, NC. This contract role involves conducting investigations related to site deviations and performing root cause analysis in a GMP environment. Ideal candidates will have 3–5+ years of experience in FDA-regulated settings, strong documentation skills, and knowledge of cGMPs. The position offers competitive pay and opportunities for continuous improvement initiatives within the organization.

Qualifications

• 3–5+ years of experience in a pharmaceutical, biotech, or FDA-regulated GMP environment.
• Hands-on experience conducting deviation and OOS investigations.
• Strong understanding of cGMPs, FDA regulations, and quality systems.

Responsibilities

• Conduct investigations related to site exceptions and deviations.
• Perform Phase II OOS investigations and support root cause analysis.
• Identify root causes and develop appropriate corrective actions.

Skills

Investigation experience

Root cause analysis

Collaboration across departments

Documentation practices

Education

Bachelor’s degree in Chemistry, Microbiology, Biology, Engineering, or related science

Tools

SAP

Microsoft Office

Job description

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company that is hiring for a Quality Investigator. This is a contract opportunity with potential for hire, offering competitive pay and the opportunity to work in a highly regulated GMP manufacturing environment. The ideal candidate has strong investigation experience, hands‑on root cause analysis exposure, and the ability to work cross‑functionally to drive compliance and continuous improvement initiatives.

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.