Deviation Investigator - API Manufacturing

Deviation Investigator – API Manufacturing Duration: Contract Position Summary We are seeking an experienced Deviation Investigator with hands-on API (Active Pharmaceutical Ingredient) manufacturing experience to support investigation and remediation activities within a GMP-regulated manufacturing environment. This role will focus on leading deviation investigations, performing root cause analysis, driving CAPA activities, and partnering closely with Manufacturing, Quality, and Technical Operations teams to ensure timely resolution of quality events. Key Responsibilities Lead deviation investigations from initiation through closure. Conduct thorough root cause analysis using methodologies such as 5 Why, Fishbone, 6M, and Cause & Effect Analysis. Author clear, accurate, and GMP-compliant investigation reports. Develop and support implementation of Corrective and Preventive Actions (CAPAs). Evaluate CAPA effectiveness and support continuous improvement initiatives. Collaborate with Manufacturing, Quality Assurance, Quality Control, and Technical Operations teams to resolve quality events. Support backlog investigation remediation efforts and drive timely closure of investigations. Assist with updates to SOPs, manufacturing documentation, and quality records as needed. Provide technical support for manufacturing process investigations and troubleshooting activities. Required Qualifications Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or a related field. Experience performing deviation investigations within a GMP-regulated pharmaceutical, biotechnology, or API manufacturing environment. Hands-on experience supporting API manufacturing operations. Strong understanding of root cause analysis methodologies and investigation practices. Experience with CAPA development, implementation, and effectiveness verification. Strong technical writing and documentation skills.Ability to work cross-functionally with Manufacturing, QA, QC, and Operations teams. Preferred Qualifications Experience supporting batch record investigations. Knowledge of Quality Operations processes. Experience with backlog investigation remediation projects. Experience troubleshooting manufacturing processes in a pharmaceutical or biotechnology setting. Familiarity with regulatory requirements and GMP documentation practices. Ideal Candidate The ideal candidate has practical, shop-floor investigation experience and can clearly demonstrate how they have led manufacturing investigations, identified root causes, implemented CAPAs, and measured investigation effectiveness within an API manufacturing environment. #J-18808-Ljbffr Intellectt Inc