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 compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are effectively developed, implemented, and documented. The position plays a key role in maintaining high quality standards, supporting audits and inspections, and driving continuous improvement across operations.

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 methodologies such as fishbone analysis and 5 Whys.
• Collaborate with cross-functional teams to develop robust corrective and preventive actions (CAPAs) that address root causes and prevent recurrence.
• Implement and track CAPAs to completion, ensuring actions are effective and sustainable.
• Maintain accurate, detailed, and compliant records of all deviations, investigations, and associated CAPAs.
• Prepare clear, well-structured deviation and investigation reports for internal stakeholders and regulatory authorities as required.
• Ensure all documentation complies with Good Documentation Practices (GDP) and internal quality standards.
• Ensure that all deviation management activities comply with applicable company policies, Good Manufacturing Practices (GMP), and regulatory requirements.
• Support internal and external audits and inspections by providing complete and organized deviation and CAPA documentation, as well as explanations of investigation approaches and outcomes.
• Analyze deviation data and trends to identify systemic issues and opportunities for process improvement.
• Provide insights and recommendations to support continuous improvement initiatives in quality, operations, and deviation management processes.
• Participate in and, when appropriate, contribute to training programs related to deviation management, root cause analysis, CAPA, and quality assurance.
• Conduct investigations in aseptic environments, including isolator lines, ensuring adherence to aseptic techniques and contamination control principles.

• At least 2 years of experience working in a pharmaceutical environment performing GMP investigations.
• Strong knowledge of Good Manufacturing Practices (GMP) and their application in a pharmaceutical setting.
• Proven experience conducting root cause analysis using methods such as fishbone diagrams and 5 Whys.
• Demonstrated technical writing skills with a track record of authoring clear, comprehensive deviation and investigation reports.
• Experience conducting investigations in aseptic environments, including work on isolator lines.
• Strong analytical and problem-solving skills with the ability to interpret data and identify root causes.
• Thorough understanding of corrective and preventive action (CAPA) processes and their implementation.
• Familiarity with Good Documentation Practices (GDP) and strict adherence to documentation standards.

• Experience with process improvement initiatives related to quality, deviation reduction, or operational efficiency.
• Ability to collaborate effectively with cross-functional teams in quality, operations, and other support functions.
• Strong attention to detail and organizational skills to manage multiple investigations and documentation requirements.
• Effective verbal and written communication skills to present findings and recommendations to various stakeholders.
• Commitment to continuous learning in deviation management, quality assurance, and regulatory expectations.

This role operates in a regulated pharmaceutical environment with a strong focus on GMP, aseptic processing, and quality standards. The typical schedule is Monday through Friday from 8:00 a.m. to 5:00 p.m., with some flexibility in hours as needed. Approximately 10 hours of overtime per week are expected to support investigation timelines, documentation, and audit readiness. The position involves working in and around aseptic areas and isolator lines, requiring adherence to established gowning, hygiene, and contamination control practices. Interviews for this role take place in person, and the work involves close collaboration with quality and operations teams in an office and production setting.

Job Type & Location

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

The pay range for this position is $50.00 - $50.00/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)

This is a fully onsite position in Greenville,NC.

This position is anticipated to close on Apr 29, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $50