Deviation Investigator

Job Title: Deviation Investigator

The Deviation Investigator is responsible for identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, and regulatory requirements within a pharmaceutical environment. This role ensures that all deviations are handled in full compliance with company policies, Good Manufacturing Practices (GMP), and industry regulations, and that corrective and preventive actions (CAPAs) are effectively implemented to support product quality and continuous improvement.

Responsibilities

• Identify and document deviations from standard operating procedures (SOPs), quality standards, and regulatory guidelines in a timely and accurate manner.
• Conduct thorough root cause investigations of deviations using structured methods such as fishbone analysis and 5 Whys to determine underlying issues.
• Collaborate with cross-functional teams to develop, propose, and implement effective corrective and preventive actions (CAPAs) that address identified root causes.
• Maintain accurate, complete, and well-organized records of all deviations, investigations, and CAPAs in accordance with Good Documentation Practices (GDP).
• Prepare clear, detailed deviation and investigation reports suitable for internal review and for presentation to regulatory authorities when required.
• Ensure that all deviation activities comply with company policies, GMP requirements, and applicable industry and regulatory standards.
• Participate in internal and external audits and inspections by providing documentation, explanations, and support related to deviations and investigations.
• Analyze deviation data and trends to identify recurring issues and provide insights and recommendations for continuous process and quality improvement.
• Engage in training programs and ongoing learning to enhance knowledge and skills related to deviation management, GMP, 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 initiatives by applying findings from deviation investigations to optimize procedures and reduce the occurrence of future deviations.

Essential Skills

• At least 2 years of experience working in a pharmaceutical environment performing deviation investigations under GMP conditions.
• Strong knowledge of Good Manufacturing Practices (GMP) and their application to deviation management and quality assurance.
• Proven experience in root cause analysis using structured methods such as fishbone diagrams and 5 Whys.
• Demonstrated analytical and problem-solving skills with the ability to interpret data and identify underlying causes of deviations.
• Technical writing experience with a proven track record of drafting clear, detailed, and compliant investigation and deviation reports.
• Experience conducting investigations in an aseptic environment, including work on isolator lines and understanding of aseptic processing principles.
• Familiarity with corrective and preventive action (CAPA) processes, including development, documentation, and follow-up of CAPA plans.
• Strong attention to detail and commitment to maintaining accurate and compliant documentation in line with Good Documentation Practices (GDP).

Additional Skills & Qualifications

• Experience or training in process improvement methodologies and the ability to apply investigation outcomes to enhance processes.
• Background in quality assurance or quality systems within a regulated pharmaceutical or life sciences environment.
• Ability to collaborate effectively with cross-functional teams and communicate investigation findings clearly to diverse stakeholders.
• Strong organizational skills and the ability to manage multiple investigations and documentation requirements simultaneously.
• Commitment to continuous learning and participation in training programs related to deviation management, GMP, and quality systems.

Work Environment

This role operates in a regulated pharmaceutical setting with a focus on GMP and aseptic processing, including work on isolator lines. The standard schedule is Monday through Friday from 8:00 a.m. to 5:00 p.m., with flexibility as needed and an expectation of approximately 10 hours of overtime per week. The position is offered as a 12‑month contract with substantial opportunity for conversion to a permanent role. Interviews are conducted face to face. The environment emphasizes quality, compliance, and continuous improvement, with collaboration across quality, operations, and other functional teams.

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 Sep 8, 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 actalentaccommodation@actalentservices.com 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.