*NEW* Micro Lab Analyst / Microbiologist (Full-time / Immediate) #HJG

• Serve as a Subject Matter Expert (SME) for microbiological and sterility assurance tests
• Lead and conduct method training for new lab personnel
• Initiate and investigate deviations using the Trackwise system and Laboratory Investigations (LI)
• Manage change control tasks in Trackwise and participate in root cause analysis (RCA) investigations
• Review and approve QC test results
• Assist in audit preparation and present during inspections
• Lead Lean Green Belt (LGB) and cost-saving projects when tasked
• Participate in method validation, studies, and equipment qualification activities
• Write reports including trend reports, technical reports, investigation reports, and validation reports
• Revise Standard Operating Procedures (SOPs) and perform Environmental, Health & Safety (EHS) Risk Assessments
• Compile and trend data on a monthly basis
• Manage inventory and purchase consumables for testing
• Apply 5S methodology to improve lab areas
• Ensure good housekeeping and inventory management to prevent testing delays

• Perform equipment relocation tasks when required
• Conduct equipment qualifications, ensuring all documentation complies with global procedures
• Perform Environmental Monitoring for Pharmaceutical Quality (EMPQ) for new room qualifications
• Coordinate with vendors for equipment qualification (IOPQ) and arrange calibration

• Perform microbiological testing, including environmental monitoring (EM), plate reading, and plate verification
• Conduct microbiological tests on critical utilities, raw materials, in-process/ Bulk Drug Substances (BDS), and investigational samples
• Perform sterilization cycles using qualified autoclaves and depyrogenation cycles
• Support aliquoting of Process and Non-Protein samples on a daily basis
• Replenish lab inventory as needed

• Comply with all applicable Environmental, Health, and Safety (EHS) regulations
• Uphold Takeda's Code of Conduct in all interactions
• Perform other duties as assigned by the supervisor

Job Requirements:

• Experience in QC testing and performing microbiological investigations is preferred
• Experience in conducting microbiological studies, investigations, and cost-saving projects is a plus
• Proficient in cGMP quality systems and industry guidelines (e.g., Trackwise, Change Control, and documentation systems)
• Strong analytical and problem-solving skills
• Ability to train and communicate effectively with team members
• Knowledge of safety principles, practices, and procedures
• Proficient with Microsoft Office applications

EA License: 99C4599