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 team’s 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 RSTO’s 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 RSTO’s 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