Description Job Purpose: A Manufacturing Process Investigator is a professional who conducts thorough investigations into issues that arise within a manufacturing environment, focusing on deviations, non-conformances, and other quality concerns. They aim to identify the root cause of these issues, implement corrective actions, and prevent recurrence, ultimately ensuring the quality and compliance of manufacturing processes. __________________________________________________________________________________________ Essential Duties and Responsibilities: • Use available resources to manage and track workload to meet required timelines. • Prepare thorough investigation reports, ensuring accuracy, completeness, and compliance with regulatory expectations. • Conduct root cause analysis (RCA) for deviations, product complaints, and quality-related incidents. • Work closely with production and quality teams to implement corrective and preventive measures based on investigation findings. • Develop and maintain technical documentation to support manufacturing and quality processes. • Develop CAPA plans with input from operators, Subject Matter Experts (SMEs), and management to ensure effective and sustainable solutions. • Track and monitor CAPA action items to ensure timely completion and assess their effectiveness. • Escalate unresolved CAPA items to management and recommend further actions as needed. • Draft, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements (e.g., FDA, GMP) and industry best practices. • Collaborate with key stakeholders to ensure procedural updates align with internal standards, project timelines, and regulatory requirements. • Provide training on new or updated SOPs, CAPAs, and procedural changes to relevant personnel. • Ensure compliance with cGMPs, safety guidelines, and internal quality policies throughout the facility. Supplemental Functions: • Performs all other duties as assigned or apparent. • Identify and document areas for improvement in manufacturing and quality systems to enhance efficiency and compliance. • Support continuous improvement projects utilizing methodologies such as Lean and Six Sigma. • Analyze manufacturing data and trends to drive process enhancements and prevent reoccurring quality issues. Job Specifications and Qualifications: Knowledge: • Excellent technical writing skills with the ability to clearly document procedures and investigations. • Strong analytical and problem-solving abilities. • Proficiency in root cause analysis tools (e.g., Fishbone diagrams, 5 Whys). • Proficient in Microsoft Office Suite and quality management software. • Strong interpersonal and communication skills with the ability to collaborate effectively across departments. Education / Experience: • Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field preferred. • Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus. • 3+ years of experience in a Quality Assurance, Technical Writing, or Investigation role, preferably in a BFS or pharmaceutical manufacturing environment. • Strong background in SOP writing, CAPA management, investigation writing, and procedural updates. • Working knowledge of regulatory requirements (e.g., FDA, EU GMP) and industry best practices is a plus. Preferred Licensing and Certifications: • Good Manufacturing Practices Certified Professional • Certified Quality Auditor _____________________________________________________________________________ Working Conditions / Physical Requirements: • This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.