Quality Investigator

Quality Investigator

The Quality Investigator serves as an individual contributor within the QA Compliance department and works cross-functionally across the manufacturing plant to ensure that quality and regulatory compliance requirements are consistently maintained. This role leads and documents investigations, supports audits, drives continuous improvement, and helps ensure that the site remains inspection-ready through robust root cause analysis, effective CAPAs, and strong GMP documentation practices.

Responsibilities

• Investigate and complete site-related exceptions, including minor, major, and critical investigations, with coaching as needed based on departmental demands.
• Lead and perform Phase II out-of-specification (OOS) investigations in accordance with SOPs and GMP requirements.
• Identify true root causes of deviations and quality issues and recommend appropriate, effective CAPAs to prevent recurrence.
• Support external audits from regulatory agencies and customers by acting as a document runner, performing documentation pre-review, serving as a scribe, and providing other audit-related support.
• Assist the department in trending and analyzing metrics, including Cost of Poor Quality, key performance indicators, quality management reviews, and data trend analysis.
• Support data compilation and documentation for site Annual Product Reviews (APRs) and related QA compliance activities.
• Participate as a team member in site-based problem-solving or brainstorming initiatives to drive continuous improvement.
• Perform SOP revisions as needed to reflect current practices, regulatory expectations, and continuous improvement outcomes.
• Prepare GEMBA plans and conduct GEMBA walks to drive compliance, enhance quality, and improve safety at the site.
• Track the performance and status of assigned investigations and tasks through to completion and meet with management on a weekly basis to report progress.
• Exercise independent decision-making and sound personal judgment based on company policies, SOPs, and GMPs when conducting investigations and recommending actions.
• Use SAP proficiently to support investigations, documentation, and data tracking activities.
• Work safely in accordance with applicable regulations, standards, and procedures, and in a manner that eliminates unreasonable risk to health and the environment.
• Notify management of unsafe conditions or practices, unlawful activities, and activities that present unreasonable health and/or environmental risk, and report all safety or environmental incidents immediately.
• Support various information requests from corporate and other departments and interact with corporate support groups to drive global continuous improvement programs.
• Provide high-quality investigation writing, documentation, and record keeping to ensure data integrity and inspection readiness.
• Collaborate effectively with Operations, Quality, Engineering, Supply Chain, and other functions to gather information, drive investigations, and close actions.
• Perform other duties as assigned by management.

Essential Skills

• Proven ability to lead minor, major, and critical investigations, including Phase II OOS investigations, using sound judgment and GMP principles.
• Strong capability in root cause analysis, including identifying true root causes and developing effective, sustainable CAPAs that prevent recurrence.
• Deep working knowledge of FDA-regulated environments, SOPs, and current Good Manufacturing Practices (cGMPs) to ensure inspection-ready investigations and documentation.
• High proficiency in quality documentation, including investigation writing, metric trending, SOP revisions, and audit support with strong attention to detail and data integrity.
• Ability to work effectively across Operations, Quality, Engineering, and Supply Chain to gather information, drive investigations, and close CAPA actions.
• Proficiency in SAP for quality and compliance-related activities.
• Good documentation practice skills, with accuracy, completeness, and compliance with data integrity expectations.
• Strong written and verbal communication skills to support investigations, reporting, and cross-functional coordination.
• Detail-oriented approach with strong organizational skills and the ability to manage multiple investigations and tasks.
• Ability to work independently as an individual contributor and collaboratively as part of a team.
• Demonstrated ability to learn new skill sets and adapt to evolving processes and requirements.
• Minimum 35 years of experience in a pharmaceutical, biological, or other FDA-regulated industry setting.
• Ability to wear appropriate personal protective equipment (PPE) as required.
• Ability to lift, carry, push, or pull up to 40 lbs as needed for the role.
• Frequent use of hands and fingers for typing, operating printers, and reviewing documentation.
• Ability to sit, stand, and walk for extended periods of time in an office and manufacturing environment.

Additional Skills & Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or another science-related discipline is preferred.
• Relevant job experience may be considered in lieu of a formal degree.
• Familiarity and skilled competency with computers and common business applications.
• Proficiency with MS Office software, including Word, Excel, and Outlook.
• Self-organized and able to prioritize work effectively to meet deadlines and manage multiple assignments.
• Comfort working in a fast-paced, regulated manufacturing environment with frequent cross-functional interactions.
• Strong problem-solving mindset with a focus on continuous improvement and prevention of recurrence.
• Ability to support corporate and site-level continuous improvement initiatives and global programs.

Work Environment

This role operates primarily on a first-shift schedule, Monday through Friday, from 8:00 a.m. to 4:30 p.m., with the expectation to report on site at the manufacturing plant during these hours. Weekend work may be required based on business needs. The position is based in an office setting within a manufacturing plant, with frequent use of computer systems for documentation, investigations, and data analysis. The Quality Investigator will periodically visit laboratory, manufacturing, warehouse, and other plant areas, and may be required to gown and enter cleanroom-classified production areas in accordance with site procedures. The environment may include exposure to standard manufacturing noise and typical plant conditions. The role involves regular movement throughout the facility, including sitting, standing, and walking for extended periods. Appropriate PPE and gowning are required when entering designated areas, and adherence to all safety, environmental, and GMP requirements is expected.

Job Type & Location

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

Pay and Benefits

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

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Wilson, NC.

Application Deadline

This position is anticipated to close on Sep 7, 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.