Quality Investigator

Job Description

Job Description

Job Title: Quality Investigator

Job Description

The Quality Investigator serves as an individual contributor within the QA Compliance department and works cross‑functionally across the plant to ensure that quality and compliance requirements are consistently maintained. This role leads and documents investigations, identifies root causes, recommends and tracks corrective and preventive actions, and supports audits and continuous improvement initiatives within an FDA‑regulated manufacturing environment.

Responsibilities

• Investigate and complete site-related exceptions, including minor, major, and critical investigations, in alignment with departmental priorities and timelines.
• Lead and perform Phase II out-of-specification (OOS) investigations, ensuring thorough, inspection-ready documentation that complies with GMP expectations.
• Identify true root causes of deviations and non-conformances and recommend appropriate, sustainable corrective and preventive actions (CAPAs) to prevent recurrence.
• Support external audits and inspections by regulatory agencies and customers, including activities such as document running, documentation pre-review, and acting as a scribe.
• Assist the department in trending and analyzing quality 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 other quality reports as required.
• Participate as a team member in cross-functional problem-solving and brainstorming initiatives to drive continuous improvement across the site.
• Revise, update, and create Standard Operating Procedures (SOPs) as needed to reflect current practices and regulatory expectations.
• Prepare GEMBA plans and conduct GEMBA walks to drive compliance, enhance quality, and improve safety at the site.
• Track the progress and performance of assigned investigations and tasks through to completion, and meet with management on a regular basis to report status and escalate issues as needed.
• Make independent decisions and exercise sound personal judgment based on company policies, SOPs, and GMP requirements when executing investigations and quality activities.
• Utilize SAP and other electronic systems to document investigations, track CAPAs, and manage quality records.
• Work safely in accordance with applicable regulations, standards, and procedures, and act in a manner that minimizes risk to health and the environment.
• Promptly notify management of unsafe conditions or practices, unlawful activities, or activities that present unreasonable health or environmental risk, and report all safety or environmental incidents immediately.
• Support various information requests from corporate and other departments, and collaborate with corporate support groups to help drive global continuous improvement programs.
• Perform other quality and compliance-related duties as assigned by management.

Essential Skills

• Proven ability to lead minor, major, and critical quality investigations, including Phase II OOS investigations, using sound judgment and GMP principles.
• Strong capability in root cause analysis, including the ability to identify true root causes and develop effective, sustainable CAPAs.
• Deep working knowledge of FDA-regulated environments, including SOPs, cGMP requirements, and inspection expectations.
• High proficiency in quality documentation, including investigation writing, metric trending, SOP revisions, and audit support, with strong attention to detail and data integrity.
• Demonstrated ability to work effectively across Operations, Quality, Engineering, Supply Chain, and other functions to gather information, drive investigations, and close actions.
• Minimum of 3–5 years of experience in a pharmaceutical, biological, or other FDA-regulated industry setting.
• Good documentation practice skills and strong written and verbal communication skills to support investigations and cross-functional coordination.
• Ability to work both as an individual contributor and as part of a team, with strong self-organization and follow-through.
• Proficiency in SAP for quality and documentation-related activities.

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 degree.
• Familiarity and skilled competency with computers and common business software.
• Proficiency with MS Office applications, including Word, Excel, and Outlook.
• Detail-oriented mindset with a strong focus on accuracy and data integrity.
• Demonstrated ability to learn new skill sets and adapt to evolving processes and systems.

Work Environment

This is a first-shift position, Monday through Friday, typically from 8:00 a.m. to 4:30 p.m., based on-site at a manufacturing plant. The role primarily operates in an office setting within the plant and involves frequent use of computer systems for documentation, data analysis, and communication. The position requires periodic visits to laboratories, manufacturing areas, warehouses, and other plant locations, which may involve exposure to standard manufacturing noise and typical plant conditions. The role may require periodic gowning and entry into cleanroom-classified production areas in accordance with site procedures. Personal Protective Equipment (PPE) must be worn as required. The position requires the ability to lift, carry, push, or pull up to 40 pounds; frequent use of hands and fingers for typing, operating printers, and reviewing documentation; and the ability to sit, stand, and walk for extended periods. The role requires reliable on-site presence Monday through Friday and may occasionally require weekend work based on business needs.

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

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

This is a fully onsite position in Raleigh,NC.

This position is anticipated to close on Aug 3, 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 [email protected] 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.