Senior Lab Analyst II (Microbiology)

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Job Description

Job Title: Senior Lab Analyst II (Microbiology)
Location: Woodlands, Singapore

About the role:

This position is required to perform routine microbiological testing using validated test methods and qualified instruments.

How you will contribute:

Routine Testing

• Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI) testing, microbial identification (ID), environment monitoring (EM), and plate reading.

• Microbiological sample types include critical utilities, in-process/ Bulk Drug Substances (BDS), raw materials, investigational non-routine samples.

• Perform sterilization cycle using qualified autoclave; perform depyrogenation using qualified cycle.

• Perform aliquoting on Process and Non-Protein samples on a daily basis.

• Support Lab Services team on replenishment of inventory from warehouse on a weekly basis which involved lifting of heavy items in buddy system.

Lab Maintenance (Instrument)

• Perform preventive maintenance for laboratory equipment, such as Temperature Controlled Object (TCO), Biosafety Cabinet (BSC), etc.

• Responsible for ownership of sophisticated lab equipment and conduct equipment training to respective lab personnel.

• Arrange equipment calibration with external vendor.

• Manage and maintain service contract with vendor when required.

• Perform peer review on equipment logbook.

• Perform qualification of equipment if required.

Lab Maintenance (System)

• Initiate deviation via Trackwise system and Lab Investigation (LI)when required.

• Involve in audit preparation when tasked.

• Participate, support investigation and/or own an investigation when required.

• Participate and support Continuous Improvement (CI) initiative when required.

• Revise Standard Operating Procedures (SOP), Forms and EHS Risk Assessment.

• Review and approve QC test results when tasked

• Perform data compilation and trending on a monthly basis.

• Have a good understanding on 5S methodology; report/ highlight issues or unsafe act.

• Ensure and maintain good housekeeping; ensure sufficient inventory to prevent any delays in testing.

• Owner for QC system such as TCO coordinator, documentation coordinator and etc.

• Raise or approve Permit-to-Work (PTW) when required.

General Responsibilities

• Responsibility to adhere to any applicable EHS requirements.

• Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.

• Any other duties as assigned by supervisor.

What you bring to Takeda:

Education and Experience Requirements

• Diploma or Degree in Microbiology, Biological Sciences, Life Sciences, Biotechnology or equivalent with 2-3 years of related laboratory experience.

• Preferably experience in performing QC testing.

Key Skills and Competencies

Technical Skills

• Able to understand microbiological testing method.

• Vigilant in highlight/ report issues.

• Able propose ideas/ suggestion within QC.

• Knowledge in cGMP quality system and industry guidelines e.g. GEMS, Change Control, release, documentation etc.

• Organized and detailed oriented to drive completion of assigned tasks.

• Knowledge with Microsoft Office applications.

• Knowledge of Safety principles, practices, regulations and procedure related to the work.

Mindset & Behavior

• Committed to the role assigned.

• Positive mindset and motivated.

• Able to understand constraints at times and be flexible.

• Good Interpersonal, Verbal and Written Communication Skills required.

• Ability to work and collaborate within the team.

• Good in emotional handling.

• Good time management skills

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

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, or any other characteristic protected by law.

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