Quality Investigator

Actalent; Wilson (NC); On-site; USD 83,000 - 110,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent is seeking a qualified Quality Investigator to support GMP-compliant investigations and QA reporting in a pharmaceutical manufacturing setting. The role focuses on authoring QARs, leading deviation investigations, and driving robust root cause analyses to ensure timely delivery of critical products.

Responsibilities include collaborating with Manufacturing, MSAT, Engineering, QA, and Operations, reviewing batch records, data, and SOPs, and developing CAPAs aligned with regulatory

Qualifications

• Bachelor’s degree in Science, Engineering, or related discipline.
• Minimum of 2 years of experience supporting operations-based deviations and quality investigations in GMP manufacturing.
• Proven ability to independently write, manage, and close investigations.
• Hands-on experience with eQMS, preferably Veeva Vault.

Responsibilities

• Author, manage, and maintain Quality Assurance Reports (QARs) and deviation investigations.
• Lead investigations into batch record discrepancies, process deviations, and manufacturing issues.
• Perform root cause analysis using site-approved methodologies and ensure defendable conclusions.
• Collaborate with Manufacturing, MSAT, Engineering, QA, and Operations leadership to gather information.
• Review batch records, production logs, data, and SOPs to support investigations.
• Develop impact assessments and CAPAs aligned with risk and regulatory expectations.
• Ensure timely investigations with GMP-compliant documentation.
• Support regulatory inspections and internal audits related to deviations.
• Use eQMS (Veeva Vault) to document and close deviations and CAPAs.
• Contribute to inspection readiness and continuous improvement.

Skills

GMP knowledge

Root cause analysis

Quality investigations

Technical writing

Stakeholder communication

Batch record review

Education

Bachelor’s degree in Science/Engineering

Tools

Veeva Vault

Job description

Job Title: Quality Investigator

Job Description

The Quality Investigator plays a key role in ensuring manufacturing operations remain compliant, efficient, and aligned with Good Manufacturing Practice (GMP) standards. This position focuses on authoring and managing Quality Assurance Reports (QARs), leading deviation investigations, and driving robust root cause analysis and corrective actions that support timely delivery of critical pharmaceutical products to patients.

Responsibilities

• Author, manage, and maintain Quality Assurance Reports (QARs) and deviation investigations related to manufacturing operations and process execution.
• Lead and support investigations into batch record discrepancies, process deviations, procedural issues, manufacturing execution problems, and equipment or material impacts to operations.
• Perform root cause analysis using site‑approved methodologies and ensure conclusions are well‑supported, accurate, and defendable.
• Partner directly with Manufacturing, MSAT, Engineering, Quality Assurance, and Operations leadership to gather detailed and accurate information for investigations.
• Review and interpret batch records, manufacturing documentation, production logs, alarms, process data, SOPs, work instructions, and training records to support investigations.
• Develop clear impact assessments and CAPAs that are aligned with operational risk, regulatory expectations, and site procedures.
• Ensure investigations are completed on time and in full, with thorough documentation that complies with GMP standards and internal procedures.
• Support regulatory inspections, internal audits, and quality metric reviews related to operational deviations and investigation performance.
• Use electronic quality management systems (eQMS), such as Veeva Vault, to document, track, and close deviations and CAPAs.
• Contribute to inspection readiness activities and continuous improvement initiatives within manufacturing and operations quality.

Essential Skills

• Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience.
• Minimum of 2 years of experience supporting operations‑based deviations and quality investigations in a GMP manufacturing environment.
• Proven ability to independently write, manage, and close investigations tied to manufacturing processes.
• Strong understanding of batch record review, manufacturing workflows, and GMP documentation practices.
• Hands‑on experience working in electronic quality systems (eQMS), preferably including Veeva Vault.
• Demonstrated expertise in GMP, root cause analysis, CAPA development, and deviation management.
• Excellent technical writing skills with the ability to produce clear, concise, and compliant investigation reports.
• Strong critical thinking and analytical skills to interpret complex manufacturing and process data.
• Effective stakeholder communication skills, with the ability to collaborate across Manufacturing, MSAT, Engineering, QA, and Operations.

Additional Skills & Qualifications

• Direct experience supporting aseptic or sterile pharmaceutical manufacturing operations.
• Background in Manufacturing, MSAT, or Operations Quality within a high‑volume pharmaceutical environment.
• Experience supporting regulatory inspections and inspection readiness activities.
• Familiarity with quality metrics and continuous improvement in a GMP setting.
• Motivation to support critical backlog work that helps ensure timely delivery of mission‑critical products to patients and the healthcare system.

This role operates within a pharmaceutical manufacturing environment and office setting. You will work closely with production and quality teams, spending time both on the manufacturing floor and in office areas to review documentation, process data, and electronic quality records. The environment is governed by strict GMP standards, established procedures, and regulatory expectations, with regular interaction with electronic quality systems and manufacturing documentation to support compliant and efficient operations.

Job Type & Location

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

Pay And Benefits

The pay range for this position is $60.00 - $80.00/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 16, 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 [e-mail] 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.