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.

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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

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Working Conditions / Physical Requirements:

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