Manufacturing Lead Investigator

Role Summary

The Manufacturing Lead Investigator initiates and executes deviations in support of Manufacturing, defines problem statements, documents current state, conducts root cause analysis, and implements corrective actions with verification of effectiveness. The role provides technical support to filling, inspection, and packaging operations and collaborates with manufacturing, quality assurance, and critical systems personnel to investigate suspect results. It also leads investigation teams and prepares presentations for management. Location: USA - IL - Round Lake - Drug Delivery.

Responsibilities

• Conduct and document investigations in a timely manner to support the on-time closure of non-conformances to meet product fulfillment dates.
• Support problem-solving sessions using problem-solving tools and methods to coordinate and/or lead investigation teams. Lead routine and complex investigations.
• Actively contribute to a team setting, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support as needed. Lead or support Deviation Free Initiatives.
• Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate 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 those databases as they pertain to CAPA and other quality databases.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents when assigned.
• Ensure training requirements are met and that training records are current. Train and mentor other team members and support training for newer team members.
• Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).

Qualifications

• Typically requires a bachelor’s degree in science, engineering or other 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 up.
• Capable of navigating through Quality systems and has working knowledge of event management system.

Education

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

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.