Manufacturing Process Investigator

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 lbs.), standing, sitting and walking throughout the facility.