Quality Investigator

Job Title: Quality Investigator Job Description The Quality Investigator plays a key role in ensuring compliant, reliable pharmaceutical manufacturing by leading investigations into deviations, authoring high-quality Quality Assurance Reports, and driving effective corrective and preventive actions. This position supports operations by analyzing process and documentation issues, partnering closely with cross-functional teams, and helping the site deliver critical products to patients on time while meeting regulatory and GMP standards. Responsibilities Author, manage, and maintain high-quality Quality Assurance Reports (QARs) for deviations related to manufacturing operations and process execution. Lead and support investigations into batch record discrepancies, process deviations, procedural issues, and manufacturing execution problems. Investigate equipment or material impacts on operations and assess their potential effect on product quality and compliance. Conduct root cause analysis using site-approved methodologies and ensure conclusions are clear, well-supported, and defendable. Partner directly with Manufacturing, MSAT, Engineering, Quality Assurance, and Operations leadership to gather accurate and complete investigation details. Review and interpret batch records, manufacturing documentation, production logs, alarms, and process data to identify trends and root causes. Evaluate and interpret SOPs, work instructions, and training records to determine procedural gaps or compliance issues. Develop robust impact assessments that clearly define product, process, and compliance risks associated with deviations. Design and propose effective Corrective and Preventive Actions (CAPAs) aligned with operational risk, regulatory expectations, and site standards. Ensure all investigations are completed on time, thoroughly documented, and fully compliant with site procedures and GMP requirements. Support regulatory inspections, internal audits, and quality metric reviews related to operational deviations and quality events. Utilize electronic quality systems (eQMS), such as Veeva Vault, to document investigations, manage workflows, and track CAPA implementation. Apply strong technical writing and critical thinking skills to produce clear, concise, and logically structured investigation reports. Contribute to inspection readiness activities by ensuring deviation and CAPA records are complete, accurate, and easily retrievable. Support backlog reduction efforts to help the site release products to patients on time and maintain a reliable supply to the healthcare system. Essential Skills Bachelor’s degree in Science, Engineering, or a related discipline, or equivalent GMP manufacturing experience. At least 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 and manufacturing workflows in a regulated environment. Solid knowledge of GMP documentation practices and compliance expectations. Hands-on experience working in electronic quality management systems (eQMS), including platforms such as Veeva Vault. Demonstrated proficiency in root cause analysis methodologies within a GMP setting. Experience developing and managing Corrective and Preventive Actions (CAPA) to address deviations and systemic issues. Strong technical writing skills with the ability to create clear, accurate, and well-structured investigation reports. Excellent critical thinking and problem-solving skills applied to complex manufacturing and quality issues. Effective stakeholder communication skills, with the ability to collaborate with cross-functional teams in Manufacturing, MSAT, Engineering, QA, and Operations. Direct experience supporting aseptic or sterile manufacturing operations. Additional Skills & Qualifications Prior experience at a high-volume pharmaceutical manufacturing site. Experience supporting regulatory inspections and inspection readiness activities. Background in Manufacturing, MSAT, or Operations Quality. Experience interpreting production logs, alarms, and process data to support investigations. Familiarity with quality metrics and their use in monitoring deviation trends and process performance. Work Environment This role operates within a pharmaceutical manufacturing environment and associated office areas. You will work closely with operations and quality teams in a GMP-regulated setting, regularly interacting with production documentation, electronic quality systems, and process data. The environment emphasizes compliance, attention to detail, and collaboration, as you help support critical backlog work and ensure products reach patients on time. The position involves a mix of time spent in office-based activities, such as authoring reports and reviewing records, and engagement with manufacturing operations to gather information and support investigations. Job Type & Location This is a Contract position based out of Rocky Mount, NC. Pay And Benefits The pay range for this position is $60.00 - $80.00/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 Rocky Mount,NC. Application Deadline This position is anticipated to close on Aug 10, 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 click.appcast.io 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. #J-18808-Ljbffr