Quality Investigator

Job Title:

Quality Investigator

The Quality Investigator is an individual contributor role within the QA Compliance department. This position requires collaboration across various plant functions to ensure quality and compliance standards are upheld.

• Investigate and complete site-related exceptions, including minor, major, and critical investigations, with guidance as needed.

• Identify root causes and recommend appropriate corrective and preventive actions (CAPAs).

• Conduct Phase II Out of Specification (OOS) investigations.

• Support external audits from regulatory agencies and customers by serving as a document runner, documentation pre-reviewer, or scribe.

• Assist in trending metrics such as Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, and Data Trend Analysis.

• Compile data for site Annual Product Reviews (APRs).

• Participate in team initiatives for continuous improvement.

• Revise Standard Operating Procedures (SOPs) as necessary.

• Prepare GEMBA plans and conduct walks to ensure compliance and safety improvements.

• Track assignment performance and report progress to management weekly.

• Make independent decisions and personal judgments based on company policies, SOPs, and GMPs.

• Demonstrate proficiency in SAP.

• Perform other duties as assigned by management.

• Experience in deviation investigations and root cause analysis.

• Strong understanding of Good Manufacturing Practices (GMP) and FDA-regulated environments.

• Ability to collaborate across Operations, Quality, Engineering, and Supply Chain.

• Proficiency in quality documentation, including investigation writing and SOP revisions.

• Bachelor’s degree in chemistry, microbiology, biology, or engineering preferred; other science-related degrees considered.

• 3-5 years of experience in a pharmaceutical, biological, or other FDA-regulated industry.

• Familiarity with computers and MS Office software (Word, Excel, Outlook).

• Ability to wear appropriate Personal Protective Equipment (PPE).

• Capability to lift, carry, push, or pull up to 40 lbs.

• Strong written and verbal communication skills.

• Detail-oriented and self-organized.

• Ability to work both independently and as part of a team.

• Demonstrated ability to learn new skills.

The position operates within a first shift schedule from Monday through Friday, 8 am to 4:30 pm. It includes visits to laboratory, manufacturing, warehouse, and other plant areas, with a primary office setting at a manufacturing plant. Frequent use of computer systems is required, and entry into cleanroom classified production areas may be necessary. The work environment might expose the individual to standard manufacturing noise.

The position requires reporting to the plant on weekdays, with potential weekend work if needed.

This is a Contract position based out of Raleigh, NC.

The pay range for this position is $45.00 - $49.00/hr.

Benefits for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Raleigh, NC.

This position is anticipated to close on Apr 23, 2026.

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.