Manufacturing Principal Investigator I

Job description

Nature and Scope As a member of the Manufacturing department, the Principal Investigator I ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies, and cGMPs. This is a cross-functional position that interacts with Quality Systems, Manufacturing, Materials Management, Maintenance and QC-Microbiology. This position generates investigation summaries for all departments within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions. The Principal Investigator I also has responsibilities in the data entry, generation and evaluation of process and performance metrics. The Principal Investigator I also has a critical role in maintaining production schedules and meeting Company goals. Essential Duties and Responsibilities: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. - Ensure event and deviation timelines are maintained through inter-department communication. - Periodically summarize and...