Deviation Investigator

Actalent; Greenville (NC); On-site; USD 57,000 - 81,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Plan

Life Insurance

Disability insurance

Health Spending Account

Transportation benefits

Employee Assistance Program

PTO & Vacation

Job summary

Actalent is seeking a Deviation Investigator in Greenville, NC to identify, document, investigate, and resolve deviations from SOPs and regulatory standards within a GMP environment. The role emphasizes CAPA development, trend analysis, and cross-functional collaboration to prevent recurrence.

Responsibilities include conducting root-cause investigations, ensuring GDP-compliant records, and presenting findings to stakeholders and regulators.

Qualifications

• 2+ years in pharmaceutical investigations under GMP
• Strong GMP principles in deviation management and GDP
• Proven root cause analysis with fishbone/5 Whys
• Clear, compliant investigation reports writing
• Experience in aseptic environments and isolator lines
• Detail-oriented documentation aligned with GDP
• Collaborative with cross-functional teams during investigations

Responsibilities

• Identify and document deviations from SOPs and regulatory guidelines.
• Conduct structured investigations to determine root causes.
• Develop and implement CAPAs with cross-functional teams.
• Track CAPAs for timely completion and effectiveness verification.
• Maintain compliant records per GDP.
• Prepare written investigation reports for internal/regulatory review.
• Present findings and CAPA status to stakeholders.
• Ensure deviation activities align with GMP and regulatory requirements.
• Participate in audits and inspections providing documentation.
• Analyze deviation trends for process improvements.
• Support continuous improvement of quality systems.
• Participate in training on deviation management and QA.
• Conduct investigations in aseptic environments including isolator lines.
• Support process improvements based on deviation insights.

Skills

GMP knowledge

Root cause analysis

CAPA development

Technical writing

Investigations in GMP

Aseptic environment

Documentation practices

Cross-functional collaboration

Job description

Job Title: Deviation Investigator Job Description

The Deviation Investigator identifies, documents, investigates, and resolves deviations from standard procedures, protocols, and regulatory requirements within a pharmaceutical environment. This role ensures that all deviations are managed in compliance with internal policies and industry regulations, and that corrective and preventive actions (CAPAs) are effectively developed, implemented, and monitored. The Deviation Investigator supports continuous improvement by analyzing deviation trends and contributing to process enhancements across the organization.

Responsibilities

• Identify and document deviations from standard operating procedures (SOPs), quality standards, and regulatory guidelines in a timely and accurate manner.
• Conduct thorough, structured investigations to determine the root cause of deviations, using established methodologies such as fishbone diagrams and 5 Whys.
• Collaborate with cross-functional teams to develop robust corrective and preventive actions (CAPAs) that address identified root causes and prevent recurrence.
• Implement and track CAPAs, ensuring actions are completed on schedule and verified for effectiveness.
• Maintain accurate, detailed, and compliant records of all deviations, investigations, and CAPAs in accordance with Good Documentation Practices (GDP).
• Prepare clear and comprehensive written investigation reports suitable for internal review and potential regulatory inspection.
• Present deviation findings, investigation outcomes, and CAPA status to stakeholders and, when required, to regulatory authorities.
• Ensure all deviation management activities align with company policies, Good Manufacturing Practices (GMP), and applicable regulatory requirements.
• Participate in internal and external audits and inspections by providing complete and accurate documentation and responding to questions related to deviations and investigations.
• Analyze deviation trends and metrics to identify systemic issues, recurring problems, and opportunities for process improvement.
• Contribute to, and support continuous improvement initiatives aimed at strengthening quality systems and reducing deviation occurrence.
• Participate in training programs to enhance knowledge and skills related to deviation management, root cause analysis, and quality assurance.
• Conduct investigations in aseptic environments, including work on isolator lines, ensuring adherence to aseptic techniques and contamination control practices.
• Support process improvement efforts by providing insights from deviation investigations and recommending enhancements to procedures, processes, and controls.

Essential Skills

• At least 2 years of experience working in a pharmaceutical environment performing investigations under Good Manufacturing Practice (GMP) requirements.
• Strong knowledge of GMP principles and their practical application to deviation management and quality systems.
• Demonstrated proficiency in root cause analysis, including hands‑on experience using fishbone diagrams and 5 Whys methodologies.
• Proven technical writing skills with experience authoring clear, detailed, and compliant investigation reports.
• Experience conducting investigations in an aseptic environment, including work on isolator lines.
• Strong analytical and problem-solving abilities with a structured approach to identifying and resolving issues.
• Ability to interpret and apply standard operating procedures (SOPs), quality standards, and regulatory guidelines.
• High attention to detail and accuracy in documentation in alignment with Good Documentation Practices (GDP).
• Effective collaboration skills to work with cross‑functional teams during investigations and CAPA development.

Additional Skills & Qualifications

• Experience with process improvement initiatives related to quality systems or manufacturing operations.
• Familiarity with continuous improvement methodologies and tools used to reduce deviations and enhance process robustness.
• Comfort presenting investigation findings and CAPA plans to stakeholders and supporting audit and inspection activities.
• Ongoing commitment to professional development through training in deviation management, quality assurance, and related topics.

Work Environment

This role operates in a regulated pharmaceutical environment with a focus on GMP and aseptic processing. The standard work schedule is Monday through Friday from 8:00 a.m. to 5:00 p.m., with flexibility to accommodate business needs. Approximately 10 hours of overtime per week are expected. The position is offered as a 12‑month contract with substantial opportunity for conversion to a permanent role based on performance and business requirements. Interviews are conducted face to face. The work involves frequent interaction with documentation systems, quality systems, and cross‑functional teams, as well as time spent in aseptic areas and on isolator lines, following appropriate gowning and contamination control practices.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $50.00 - $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 Greenville, NC.

Application Deadline

This position is anticipated to close on Oct 6, 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.

Equal Opportunity Employment

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.

Accommodation Request

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.