Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Deviation Investigator

Position Summary

The Deviation Investigator is responsible for supporting the investigation, documentation, and timely resolution of manufacturing deviations within the aseptic manufacturing setting. This position works closely with Manufacturing, Quality Assurance (QA), Quality Control (QC), Engineering, and other cross-functional teams to ensure deviations are thoroughly investigated, accurately documented, and resolved in accordance with current Good Manufacturing Practices (cGMP), site procedures, and regulatory requirements.

The ideal candidate will have 1–2 years of experience in technical writing, deviation documentation, quality investigations, or a related pharmaceutical manufacturing function. Strong written communication skills, attention to detail, and the ability to organize complex technical information into clear, factual, and well-structured investigation reports are essential.

This is an opportunity for an individual who has foundational experience in GMP documentation and is looking to further develop their investigation, technical writing, and problem-solving skills within a sterile pharmaceutical manufacturing environment.

Key Responsibilities

Deviation Investigation and Documentation

• Author and support deviation investigations associated with sterile pharmaceutical manufacturing operations within Building 16.
• Develop clear, accurate, and comprehensive investigation reports that document the sequence of events, investigation 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.
• Conduct interviews with manufacturing personnel and subject matter experts to establish factual event timelines and support investigation findings.
• Collaborate with cross-functional teams to identify potential contributing factors and determine appropriate investigation scope.
• Support root cause analysis activities using established methodologies, including 5-Why analysis, Fishbone diagrams, and other approved investigation tools.
• Ensure investigation conclusions are supported by documented evidence and sound technical rationale.

Technical Writing and Quality Documentation

• Prepare well-organized, technically accurate, and grammatically correct deviation reports for review and approval.
• Translate complex manufacturing events and technical findings into clear, concise, and objective written narratives.
• Ensure investigation reports follow established documentation standards, including Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
• Review investigation content for completeness, consistency, accuracy, and appropriate 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 within the Global TrackWise quality management system.

Cross-Functional Collaboration

• Work closely 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 an understanding of sterile manufacturing processes, equipment, and operational controls to improve investigation effectiveness.

Minimum Qualifications

Education

• Associate's degree in a scientific, technical, engineering, or related discipline with 1 year relevant experience; or
• Bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field preferred.

Experience

• 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.

Preferred Qualifications

• 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.

Required Skills and Competencies

• Strong technical writing skills: Ability to produce clear, factual, logically organized, and technically accurate investigation reports.
• Attention to detail: Ability to identify missing information, inconsistencies, and documentation errors.
• Analytical thinking: Ability to review evidence, identify relevant facts, and support evidence-based conclusions.
• Communication: Effective written and verbal communication with personnel across multiple departments.
• Organization and time management: Ability to manage multiple investigations, prioritize tasks, and meet established deadlines.
• Collaboration: Ability to work effectively with cross-functional teams and incorporate technical and quality feedback.
• Learning agility: Willingness to develop technical knowledge of sterile manufacturing operations and quality investigation practices.
• Quality mindset: Commitment to data integrity, regulatory compliance, and continuous improvement.

Position Expectations

The successful candidate will be expected to develop proficiency in deviation investigation writing, Global TrackWise documentation, and sterile manufacturing processes.

With appropriate training and guidance, the individual should demonstrate increasing independence in gathering investigation evidence, preparing deviation narratives, supporting root cause analysis, and addressing reviewer feedback.

The position requires the ability to balance investigation quality with timely completion while maintaining accurate documentation and effective communication with Manufacturing and Quality stakeholders.

Work Environment

This 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.