Quality Investigator

Job Title: Quality InvestigatorJob Description

We are seeking a dedicated Quality Investigator to join our QA Compliance department. As an individual contributor, you will work cross-functionally to maintain quality and compliance standards across the plant. This role is pivotal in ensuring the integrity of our processes and products.

Responsibilities

• Investigate and complete site-related exceptions, including minor, major, and critical investigations, with coaching as needed.
• Identify root causes and recommend appropriate Corrective and Preventive Actions (CAPAs) to address these causes.
• Perform Phase II Out of Specification (OOS) investigations.
• Support external audits from regulatory agencies and customers, including roles such as Document Runner, Documentation Pre-Review, and 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 brainstorming initiatives for continuous improvement.
• Revise Standard Operating Procedures (SOPs) as needed.
• Prepare GEMBA plans and conduct compliance and safety improvement walks.
• Track and report the progress of assignments to management weekly.
• Make independent decisions and exercise personal judgment based on company policies, SOPs, and Good Manufacturing Practices (GMPs).
• Utilize SAP proficiently.
• Perform other duties as assigned by management.

Essential Skills

• Proficiency in deviation investigations, root cause analysis, and GMP compliance.
• Proven ability to lead investigations, including Phase II OOS, using sound judgment and GMP principles.
• Strong capability to identify true root causes and develop effective, sustainable CAPAs.
• Deep working knowledge of FDA-regulated environments, SOPs, and cGMP requirements.
• Ability to work effectively across Operations, Quality, Engineering, and Supply Chain.
• High proficiency in investigation writing, metric trending, SOP revisions, and audit support with attention to detail and data integrity.

Additional Skills & Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or other science-related fields preferred.
• 3-5 years of experience in a pharmaceutical, biological, or other FDA-regulated industry setting.
• Competency with computers and MS Office software (Word, Excel, and Outlook).
• Good documentation practice skills.
• Strong written and verbal communication skills.
• Detail-oriented and self-organized.
• Ability to work independently or as part of a team.
• Demonstrated ability to learn new skill sets.

Work Environment

This position operates on the first shift, Monday through Friday, from 8am to 4:30pm. The role involves working in an office setting within a manufacturing plant, with visits to laboratories, manufacturing, warehouse, and other plant areas as needed. The position requires frequent use of computer systems and may involve periodic gowning and entry into cleanroom classified production areas. Exposure to standard manufacturing noise is possible. The role requires the ability to wear appropriate Personal Protective Equipment (PPE), lift up to 40 lbs, and involves frequent use of hands and fingers for typing and reviewing documentation. The ability to sit, stand, and walk for extended periods is required. Weekend work may be necessary if needed.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $45.00 - $50.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available 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)

Workplace Type

This is a fully onsite position in Raleigh,NC.

Application Deadline

This position is anticipated to close on Jul 31, 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 actalentaccommodation@actalentservices.com 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.