Technical Operations Investigator

The Technical Operations Investigation Contractor is responsible for overseeing, conducting, and documenting investigations related to deviations, nonconformances, and quality events. This role ensures timely, thorough, and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills, technical writing expertise, and the ability to collaborate across cross functional teams. Key Responsibilities: Lead end to end investigations for deviations and quality eventsGather and analyze data, interview personnel, and review documentation to understand event detailsApply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree,)Ensure investigations are completed within required timelines and meet regulatory and internal quality standardsIdentify true root causes supported by evidenceDevelop effective CAPA plans that address root causes and prevent recurrencePartner with process owners to ensure CAPA implementation, effectiveness checks, and closurePrepare clear, concise, and compliant investigation reportsEnsure documentation meets GMP, and regulatory expectationsMaintain high standards of accuracy, clarity, and traceabilityWork closely with Operations, Quality Assurance, Engineering, Maintenance, and other departmentsFacilitate investigation meetings and lead cross functional problem solving sessions Requirements BS in engineering, chemistry, biology or life science related field2+ years of experience Required Knowledge & Skills Strong understanding of GMP, GDP, and regulatory expectationsExcellent technical writing and documentation skillsAbility to interpret data, trends, and process performance indicatorsStrong communication, facilitation, and interpersonal skillsAbility to manage multiple investigations simultaneously and prioritize effectively Preferred Qualifications Expertise in root cause analysis tools and structured problem solvingProficiency in CAPA development, implementation, and effectiveness evaluationExperience in pharmaceutical, biotech, medical device, or other regulated manufacturing environmentsFamiliarity with electronic quality systems (TrackWise, Veeva, etc.)Background in engineering, life sciences, or a related technical fieldStrong technical writing, data analysis, problem-solving, and organizational skillsProficiency in Excel, Word, and PowerPoint Benefits 12-month contract with possible extensionAdministrative shift