Purpose

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.

Key Responsibilities

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.

Leadership

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.

Safety, Health & Environment

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.

Lean Production System

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 / Skills / Competencies

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

QC Specialist