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Actalent
Deviation Investigator
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What they do
A Quality Assurance Auditor regularly evaluates the quality control systems in place and verifies compliance with quality and safety standards.
$57,710 / year median in the U.S.
-4% projected decline
Job Description
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.