QC Specialist

• Part of the Micro/EM Team responsible for the following:
  
• Performance of testing of EM / product stream samples to meet product release timelines and in accordance with cGMP regulations and Roche/Genentech standards.
  
• Support manufacturing operations by timely completion of testing and disposition.
  
• Continuous improvement of processes and technology in collaboration with ASAT to drive right first time and efficiencies.
  
• Qualification and validation of test methods.
  
• Supporting investigations of microbial contamination in production processes classified environments and critical utility systems.
  
• Ensuring test methods and data are generated in a compliant manner following cGMPs.
  

• Testing and review of routine and non-routine environmental raw material product related samples in accordance to the Standard Operating Procedures (SOP) and Test Methods (TM).
  
• Perform EM which includes HVAC / BSC / HLFH / VLFH sampling fingertips monitoring compressed gases and water / clean steam sampling in accordance to cGMP procedures when required.
  
• Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
  
• Prepare EM reports / trend graph for product lot release and trend data analysis.
  
• Review routine data and logbooks.
  
• General lab support including housekeeping equipment maintenance document archival maintaining logbooks and inventory of lab supplies etc.
  
• Problem solving of testing related issues as well as troubleshooting of equipment.
  
• Author and/or update existing SOPs Forms OJTs and TMs as needed.
  
• Initiate discrepancy record perform discrepancy assessment and identify corrective actions where necessary.
  
• Train other analysts on methods and/or SOP.
  
• Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
  
• Participate in internal / external audits and regulatory inspections.
  
• Raise work notification g2g shopping cart for purchase of consumables / reagent / media for Lab use. Follow up on the planned receipt Delivery orders invoices when required.
  
• Understanding of basic microbiological principles (bioburden LAL plating and counting techniques etc) and execution of intermediate techniques (DET AET).
  
• Participate in project validation and process improvement works.
  
• Perform equipment qualification / maintenance liaise with external / contract lab / vendor.
  
• Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
  
• Provide forecast for consumables / reagent / media used and facilitate in budgeting and financial planning.
  
• Perform sample receipt and storage of QC samples.
  
• Manage the life-cycle process for retain and reserve/reference samples.
  
• Manage and prepare the shipment of samples to Receiving labs.
  
  

• Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit timely and effective communications. Strive towards teams objectives/goals takes the initiative and proactively turn ideas into action to make things happen.
  
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
  
• Embody PT behaviors lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
  
• A team player and the willingness to cover other colleagues in continued support of the Micro/EM operations.
  

• Comply with all RSTOs Safety Health & Environmental (SHE) requirements never put oneself and others at safety & health risks and report any workplace accidents near misses and hazards as soon as practicable.
  
• Observe all RSTOs site security measures at all times and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.
  

• Embody PT Lean Production System (LPS) while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.
  

Requirements

• Degree in Microbiology Biology Biochemistry or any Life Sciences discipline or equivalent
  
• 1-3 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience
  
• Related working experience in a biotech or pharmaceutical operating environment is a plus
  

• Knowledge of cGMP relevant to the pharmaceutical industry
  
• Knowledge of laboratory safety procedures
  
• Able to determine when to escalate issue
  
• Ability to organize and plan effectively
  
• Good team player
  
• Demonstrate excellent verbal and written communication skills in English