Deviation Investigator - Greenville, NC

Thermo Fisher Scientific•Greenville, NC

About The Position

The Deviation Investigator supports the investigation, documentation, and timely resolution of manufacturing deviations in an aseptic manufacturing setting. The role works with Manufacturing, Quality Assurance, Quality Control, Engineering, Maintenance, Technical Support, and other cross-functional teams to ensure deviations are thoroughly investigated, accurately documented, and resolved in accordance with cGMP, site procedures, and regulatory requirements. The investigator gathers and evaluates evidence from manufacturing batch records, equipment logs, electronic systems, procedures, and other documentation; interviews personnel and subject matter experts; and prepares clear, factual investigation reports. Reports document event sequences, findings, impact assessments, root cause analysis, corrective actions, and conclusions. The role supports root cause analysis using approved tools such as 5-Why and Fishbone diagrams, and maintains investigation records and supporting documentation in the Global TrackWise quality management system. The successful candidate is expected to develop proficiency in investigation writing, TrackWise documentation, and sterile manufacturing processes. With training and guidance, the candidate will increasingly work independently to gather evidence, prepare deviation narratives, support root cause analysis, and address reviewer feedback while balancing investigation quality with timely completion. The position supports Steriles North manufacturing operations within Building 16 and may require periodic presence in manufacturing areas to review processes, gather information, and collaborate with operations personnel.

Requirements

Associate's degree in a scientific, technical, engineering, or related discipline with 1 year of relevant experience, or a bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field (preferred).
1–2 years of experience in technical writing, GMP documentation, deviation investigations, or a related regulated manufacturing environment (preferred).
Experience reviewing manufacturing records, standard operating procedures, technical reports, or quality documentation.
Basic understanding of cGMP requirements and Good Documentation Practices.
Strong technical writing skills, including the ability to produce clear, factual, logically organized, technically accurate investigation reports.
Attention to detail and ability to identify missing information, inconsistencies, and documentation errors.
Analytical thinking and ability to review evidence, identify relevant facts, and support evidence-based conclusions.
Effective written and verbal communication with personnel across multiple departments.
Organization and time-management skills, including the ability to manage multiple investigations, prioritize tasks, and meet deadlines.
Ability to work effectively with cross-functional teams and incorporate technical and quality feedback.
Willingness to develop technical knowledge of sterile manufacturing operations and quality investigation practices.
Commitment to data integrity, regulatory compliance, and continuous improvement.
Ability to lift 40 lbs. without assistance.
Adherence to all Good Manufacturing Practices (GMP) safety standards.

Nice To Haves

Bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field.
Experience in pharmaceutical, biotechnology, or sterile manufacturing environments.
Previous experience authoring or supporting deviation investigations, CAPAs, or quality event documentation.
Familiarity with TrackWise or a comparable electronic quality management system.
Knowledge of aseptic processing, sterile filling operations, environmental monitoring, equipment interventions, or manufacturing process controls.
Familiarity with root cause analysis tools such as 5-Why or Fishbone analysis.

Responsibilities

Author and support deviation investigations associated with sterile pharmaceutical manufacturing operations within Building 16.
Prepare clear, accurate, comprehensive investigation reports documenting event sequences, findings, impact assessments, root cause analysis, corrective actions, and conclusions.
Gather and evaluate information from manufacturing batch records, equipment logs, electronic systems, procedures, and other relevant documentation.
Interview manufacturing personnel and subject matter experts to establish factual event timelines and support findings.
Collaborate with cross-functional teams to identify contributing factors and determine investigation scope.
Support root cause analysis using established methodologies, including 5-Why analysis and Fishbone diagrams.
Ensure investigation conclusions are supported by documented evidence and sound technical rationale.
Prepare technically accurate, grammatically correct, well-organized deviation reports for review and approval.
Translate complex manufacturing events and technical findings into clear, concise, objective written narratives.
Follow documentation standards, including Good Documentation Practices and ALCOA+ data integrity principles.
Review investigation content for completeness, consistency, accuracy, and supporting evidence.
Incorporate feedback from QA, Manufacturing leadership, and other reviewers to improve investigation quality and facilitate timely approval.
Maintain accurate investigation records and supporting documentation in the Global TrackWise quality management system.
Work with Manufacturing, QA, QC, Engineering, Maintenance, and Technical Support personnel to obtain investigation evidence and technical information.
Communicate investigation status, outstanding information needs, and potential delays to appropriate stakeholders.
Support timely resolution of investigation questions and reviewer comments.
Develop understanding of sterile manufacturing processes, equipment, and operational controls to improve investigation effectiveness.
Balance investigation quality with timely completion while maintaining accurate documentation and effective communication with Manufacturing and Quality stakeholders.