Apply
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.
Knowledge
Job Specifications and Qualifications:
- 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.
