Sr Lab Analyst III (Integrated Testing & Support)

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Job Description

This position is required to perform routine chemistry testing, microbiological testing using validated test methods and qualified instruments, carry out QC activities to support operation such as sample management and lab maintenance etc., and lead the Shift team during the absence of the supervisor.

Responsibilities:

Routine Testing and Sample Management

• 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, pack, arrange, and coordinate samples that require external shipment.  
• Manage the backup sample in QC laboratory.
• Perform peer review for verification of task and data related to Sample Management.
• Perform data trending for Environmental, Utilities and In process.

Inventory Management

• Manage and ensure good inventory of the consumables used for testing.
• Raise Purchase order when required.
• Support replenishment of inventory from warehouse when needed which involves lifting of heavy items in a 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 equipment validation or qualification activities if required.

Lab Maintenance (System)

• Initiate deviation or laboratory investigation via Trackwise system when required.
• Support audit preparation as tasked.
• Participate, support investigation and/or own an investigation as needed.
• Participate and support Continuous Improvement (CI) initiative as needed.
• Revise Standard Operating Procedures (SOP), forms and EHS Risk Assessments.
• Perform data compilation and trending.
• Monitor the temperature for TCO equipment when tasked.
• Raise workorder to engineering or ISS on the task request.
• Have a good understanding on 5S methodology, proactively follow and support 5S workflows and report/highlight issues or unsafe acts.
• 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. when required.
• Raise or approve Permit-to-Work (PTW) when required.

General Responsibilities

• To lead the shift team in the absence of QC Supervisor or QC Lead and make arrangements on the tasks in ad-hoc situations such as team member on medical leave or urgent leave.
• To coordinate with other functions on the sample priority.
• Able to make decision for simple issues and immediately escalate the issue to supervisor when issue is unable to be resolved.
• Assist in the review and writing of SOPs related to Sample and Inventory Management.
• Identifies and report any excursion / atypical issues / safety concerns in QC to Supervisor in a timely manner.
• 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

Education and Experience Requirements

• Diploma in Chemistry, Biochemistry, Biotechnology or equivalent, preferably with more than 2-3 years of related laboratory experience.
• Knowledge in Microsoft Office application
• Experience working in cGMP Manufacturing Laboratory is preferred.
• Willing to work on rotating Day Shift (0730 to 1930 hours).
• Experience or cross trained on other QC testing (e.g., Total Organic Carbon (TOC), Conductivity testing, Microbiological and other chemical testing) will be an advantage.

Key Skills and Competencies

• Strong Planning and Organization Skills.
• Must be detail oriented.
• Vigilant to highlight/ report issues.
• Able to propose ideas/ suggestions within QC.
• Able to plan and reprioritize timely completion of testing and assigned tasks within the workday, as needed.
• Knowledge of cGMP quality system and industry guidelines e.g. GEMS, Change Control, release, documentation etc.

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