Manufacturing Lead Investigator

Overview

Join to apply for the Manufacturing Lead Investigator role at Takeda
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The Lead Investigator will initiate and execute 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. The incumbent provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. In addition, the incumbent works closely with the corresponding manufacturing, quality assurance, or critical system personnel to investigate suspect results.

Responsibilities include leading investigation teams and driving root cause identification and preparing presentation for management.

• Conduct and document Investigation in a timely manner to support the on-time closure of non-conformances to meet product fulfillment dates.
• Support problem solving sessions through application of the problem-solving tools and methods to coordinate and/or lead investigation teams. Lead routine and complex investigations.
• Actively contributes 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).

• 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.

Base pay range: $70,000.00/yr - $/yr
. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, years of relevant experience, specific skills, education level, certifications, and location. U.S. base salary range: $70,000.00 - $.

U.S. based employees may be eligible for short-term and/or long-term incentives, and may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits. Sick time and paid vacation accrual are available per calendar year.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations: USA - IL - Round Lake - Drug Delivery

Worker Type:
Employee
• Worker Sub-Type:
Regular
• Time Type:
Full time
• Job Exempt:
Yes