Senior QC Analyst II at Takeda, Microbial testing, Apply now!
At Takeda, Quality has always been a priority, reflected in our end-to-end Quality Management System. Our Singapore biologics manufacturing facility focuses on producing life-saving medicines for patients. Join us to make a meaningful impact on patients’ lives.
Job Description
Company Profile: Takeda’s Singapore biologics manufacturing facility focuses on manufacturing potentially life-saving medicines for patients suffering from rare blood disorders such as Hemophilia A and B. As part of the company’s Biologics Operating Unit network, the site is Takeda’s only biologics drug substance manufacturing facility in Asia.
Job Title: Senior QC Analyst II (Integrated Testing & Support)
Reporting To: QC Supervisor (Microbiology & Lab Service)
Location: Woodlands, Singapore
About the role: This position is required to perform routine chemistry testing, microbiological testing using validated test methods and qualified instruments, and carry out QC activities to support operation.
How you will contribute: Routine Testing
- Routine Testing
- Perform chemical analysis for water and cleaning samples using approved test method SOPs and qualified instruments.
- Perform microbiological testing, namely bioburden test, endotoxin test, Growth Promotion Testing (GPT), Biological Indicator (BI), microbial identification (ID), environmental monitoring (EM), and plate reading.
- Microbiological sample types include critical utilities, in-process / Bulk Drug Substances (BDS), raw materials, investigational and non-routine samples.
- Perform sterilization cycle using qualified autoclave, perform depyrogenation using qualified cycle.
- Perform aliquoting on Process and Non-Protein samples on daily basis
Sample Management
- Perform receiving of sample and distribution of sample
- Prepare and packing of sample that required external shipment
- Manage the backup sample in QC laboratory
Inventory Management
- Manage the inventory of the consumables used for testing.
- Raise Purchase order when required.
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.
Lab Maintenance (System)
- Initiate deviation or laboratory investigation via Trackwise system 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) and EHS Risk Assessment.
- Perform data compilation and trending.
- 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.
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 related field with relevant experience. Preferably, experience in QC testing.
- Key Skills and Competencies: Technical skills, organized and detailed, knowledge of safety principles, good communication skills, and more.
More about us: At Takeda, we are transforming patient care through novel specialty pharmaceuticals. Join us to deliver Better Health and a Brighter Future to people around the world.
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