Manufacturing Process Investigator

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