Manufacturing Process Investigator

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:

Ø Use available resources to manage and track workload to meet required timelines. Ø Prepare thorough investigation reports, ensuring accuracy, completeness, and compliance with regulatory expectations. Ø Conduct root cause analysis (RCA) for deviations, product complaints, and quality-related incidents. Ø Work closely with production and quality teams to implement corrective and preventive measures based on investigation findings. Ø Develop and maintain technical documentation to support manufacturing and quality processes. Ø Develop CAPA plans with input from operators, Subject Matter Experts (SMEs), and management to ensure effective and sustainable solutions. Ø Track and monitor CAPA action items to ensure timely completion and assess their effectiveness. Ø Escalate unresolved CAPA items to management and recommend further actions as needed. Ø Draft, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements (e.g., FDA, GMP) and industry best practices. Ø Collaborate with key stakeholders to ensure procedural updates align with internal standards, project timelines, and regulatory requirements. Ø Provide training on new or updated SOPs, CAPAs, and procedural changes to relevant personnel. Ø Ensure compliance with cGMPs, safety guidelines, and internal quality policies throughout the facility.

Supplemental Functions:

Ø Performs all other duties as assigned or apparent. Ø Identify and document areas for improvement in manufacturing and quality systems to enhance efficiency and compliance. Ø Support continuous improvement projects utilizing methodologies such as Lean and Six Sigma. Ø Analyze manufacturing data and trends to drive process enhancements and prevent reoccurring quality issues.

Job Specifications and Qualifications:

Knowledge:

Ø Excellent technical writing skills with the ability to clearly document procedures and investigations. Ø Strong analytical and problem-solving abilities. Ø Proficiency in root cause analysis tools (e.g., Fishbone diagrams, 5 Whys). Ø Proficient in Microsoft Office Suite and quality management software. Ø Strong interpersonal and communication skills with the ability to collaborate effectively across departments. Education /

Experience:

Ø Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field preferred. Ø Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus. Ø 3+ years of experience in a Quality Assurance, Technical Writing, or Investigation role, preferably in a BFS or pharmaceutical manufacturing environment. Ø Strong background in SOP writing, CAPA management, investigation writing, and procedural updates. Ø Working knowledge of regulatory requirements (e.g., FDA, EU GMP) and industry best practices is a plus.

Preferred Licensing and Certifications:

Ø Good Manufacturing Practices Certified Professional Ø Certified Quality Auditor _____________________________________________________________________________ Working Conditions /

Physical Requirements:

Ø This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.