Manufacturing Lead Investigator

Role Summary

The Lead Investigator initiates and executes deviations in support of Manufacturing. Responsibilities include defining problem statements, documenting current state, conducting root cause analysis, implementing corrective actions, and verifying that the corrective actions were effective in resolving the issue. Provides technical support to the manufacturing functions including filling, inspection, and packaging operations, and collaborates with manufacturing, quality assurance, or critical system personnel to investigate suspect results. Leads investigation teams and drives root cause identification and prepares presentations for management.

Responsibilities

• Conduct and document investigations in a timely manner to support on-time closure of non-conformances to meet product fulfillment dates.
• Support problem solving sessions through application of problem-solving tools to coordinate or lead investigation teams. Lead routine and complex investigations.
• Contribute to a team setting to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. Lead or support Deviation Free Initiatives.
• Work with QA departments and manufacturing operations to conduct investigations, determine corrective actions, and drive closure of deviations in accordance with cGMP and quality systems.
• Maintain access to key quality system databases and ensure accuracy of databases related to CAPA and other quality records.
• Maintain data integrity and ensure compliance with SOPs, FDA, GLP, QSR, and cGMP regulations. Investigate deviations and write exception documents when assigned.
• Ensure training requirements are met and training records are current. Train and mentor other team members and support training for newer team members.
• Prepare root cause and/or trend analysis for management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).

Qualifications

• Typically requires a bachelor's degree in science, engineering, or related technical field and 2+ years of related work experience. Some leadership experience preferred.
• Technical writing experience preferred.
• Ability to work independently.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills, detail oriented, and ability to plan and suggest resolutions to technical or resource problems.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills.
• Understand scientific strategies and be able to create new processes or new avenues of investigation.
• Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
• Demonstrate good process and critical system understanding to create comprehensive investigation write-ups.
• Capable of navigating through Quality systems and has working knowledge of event management systems.

Skills

• Root cause analysis
• Investigation management
• CAPA / quality systems
• Problem solving and data analysis
• Technical writing
• cGMP compliance

Education

• Bachelor's degree in science, engineering, or related technical field

Additional Requirements

• Ability to work in controlled manufacturing environments with gowning and protective equipment as required.
• Ability to work multiple shifts, including weekends, or supplemental hours as necessary.