Quality Investigator

Job Description

Job Description

Job Title: Quality Investigator Job Description

The Quality Investigator is an individual contributor role within the QA Compliance department. The position requires cross-functional collaboration throughout the plant to ensure quality and compliance requirements are maintained.

Responsibilities

• Investigate and complete site-related exceptions, including minor, major, and critical investigations with coaching based on department demands.
• Identify root cause and recommend appropriate Corrective and Preventive Actions (CAPAs) to address root cause.
• Perform Phase II Out-of-Specification (OOS) investigations.
• Support external audits from regulatory agencies and customers by acting as a Document Runner, performing Documentation Pre-Review, and serving as a Scribe.
• Assist in trending metrics such as Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, and Data Trend Analysis.
• Compile data for department requirements related to site Annual Product Reviews (APRs).
• Participate as a team member in brainstorming initiatives to drive continuous improvement.
• Perform Standard Operating Procedure (SOP) revisions as needed.
• Prepare GEMBA plans and conduct walks to drive compliance and improve safety at the site.
• Track the performance of assignments through to completion 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.

Essential Skills

• Proven ability to lead minor, major, and critical investigations, including Phase II OOS, using sound judgment and GMP principles.
• Strong capability to identify true root cause and develop effective, sustainable CAPAs that prevent recurrence.
• Deep working knowledge of FDA-regulated environments, SOPs, and cGMP requirements to ensure inspection-ready investigations and documentation.
• Ability to work effectively across Operations, Quality, Engineering, and Supply Chain to gather information, drive investigations, and close actions.
• High proficiency in investigation writing, metric trending, SOP revisions, and audit support with strong attention to detail and data integrity.

Additional Skills & Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Biology, or Engineering is preferred; other science-related degrees may be considered.
• Actual job experience may be used in lieu of a degree.
• Minimum 3-5 years’ experience in a pharmaceutical, biological, or other FDA-regulated industry setting is required.
• Familiarity and skilled competency with computers.
• Proficiency with MS Office software (Word, Excel, and Outlook).
• Good documentation practice skills.
• Strong written and verbal communication skills to support investigations and cross-functional coordination.
• Detail-oriented and self-organized.
• Ability to work both in a team environment and as an individual contributor.
• Demonstrated ability to learn new skill sets.

Work Environment

First shift: Monday through Friday, 8 am to 4:30 pm. The position requires visits to laboratory, manufacturing, warehouse, and other plant areas. The work is primarily in an office setting at a manufacturing plant with frequent use of computer systems. Periodic gowning and entry into cleanroom classified production areas may be required. Exposure to standard manufacturing noise is possible. The role requires reporting to the plant Monday-Friday, with potential weekend work if needed.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $104000.00 - $108000.10/yr.

Guerbet internal company benefits.

Workplace Type

This is a fully onsite position in Raleigh,NC.

Application Deadline

This position is anticipated to close on Aug 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.