Position Responsibilities:
•Complete required training (e.g. cGMP, Safety, Process Work Instructions, Autonomous and/or Operational Maintenance (AM/OM), etc.) within a stipulated time frame.
•Execute tasks strictly following cGMP, Quality, Safety and Work instruction requirements.
•Ensure employees follow safety, quality requirement, and all applicable company policies at all times.
•Ensure proper housekeeping and maintain cleanliness (6S) of the working area.
•Timely report/ escalate any concerns (work-related or personal).
•Meet daily work schedule and performance expectation, factoring in equipment availability.
•Able to take on additional tasks or responsibilities when required.
•Familiar with the operational process of the area in charge, including all relevant autonomous management activities.
•Identify potential issues associated to product, process and equipment within area and work with relevant teams in implementing proactive measures and to prevent from happening or minimize incidents.
•Assist in functional testing, DNA library preparation assay for sequencing testing and qualification run for new/modified product/method equipment and engineering studies if required.
•Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.
•Ensure that the processes are compliant with Quality System and EHS requirements.
•Review completed records and documentation prior to release for production.
•Support process FMEA and Risk Analysis on the Reagent QC processes/activities on existing PNs and new NPIs transfers where applicable.
•Improvement work:
o Assist in developing procedures, work instructions, guidance, best practice protocol such as checklists and troubleshooting guidelines under broad direction.
o Revise and update Standard Operating Procedures, system or processes to improve compliance, efficiency and execution with guidance from LCM.
o Identify and work with LCM to implement activities to improve Turn-around-time (TAT) operational excellence and First Pass Yield (FPY) within QC and alignment across departments.
o Constantly review procedures and processes and work closely with key internal partners to provide recommendations for improvements under broad direction.
o Execute change management process.
•Failed Testing and incident Investigation:
o Able to guide and lead technician to troubleshoot issues related to QC testing.
o Assist in conducting and documenting investigations for OOS results and other discrepancies. May perform troubleshooting on discrepancy observed in
laboratory or material under broad direction.
• Learning and Development:
o Assist in establishment of On-The-Job Training (OJT) for QC processes and training to technicians for test method under broad direction.
o Provide mentoring and coaching to the whole team of technicians by transferring knowledge and developing skills to improve their job performance.
• Be a role model for Reagent QC Technician 1 to 5 and Reagent QC Engineer 1.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
•Have a good understanding of Manufacturing/ Enterprise systems/ Manufacturing IOT and automations.
•Ensure compliance with cGMP, Quality, work safety instructions & practices at all times.
•Complete tasks in a safe and efficient manner.
•High level of discipline and integrity.
•Able to undertake multiple tasks.
•Able to undergo job rotation / cross training.
•Able to work in noisy environment with appropriate personal protection equipment (PPE).
•Able to work in chemical environment with appropriate personal protection equipment (PPE).
•Must be able to identify different colors for work purposes. In Illumina, we handle components/chemicals with different colors, and it is necessary to be able to differentiate and identify the correct components/chemicals (using visual) during operation.
•Possess a positive attitude and sense of urgency.
•Meticulous, keen attention to details and organized.
•Ability to multitask and manage multiple simultaneous activities in a rapidly changing environment.
•Good analytical skills.
•Knowledge in reaction design/kinetic for enzymatic reaction.
•Team player and possess effective interpersonal and good communication skills (verbal and written).
•Good experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
•Good failure investigation, technical report writing, data mining, trend analysis.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education/Skills:
•Bachelor’s Degree in Chemistry, Analytical Chemistry or Biological/Life Sciences with 3 to 5 years of working experience in laboratory environment.
•Diploma in Science (preferably Chemistry or Biology) or Chemical Process Technology/ NTC/NITEC/ Secondary School / ‘O’ Level or equivalent with more than 6 years working experience will also be considered.
•Strong instrumentation experience. Minimum 1 year of hands-on experience in handling analytical instruments, such as Ultra/High Performance Liquid Chromatography (U/HPLC), Ion Chromatography (ICS), UV/Vis Spectrophotometer (SpectraMaxTM, NanodropTM) or liquid chromatography-mass spectrometry (LC-MS).
•Hands on experience in sample preparation using basic laboratory equipment such as micropipettes, incubator and mini-centrifuge; Chromatogram analysis for liquid samples.
•Hands-on experience and good pipetting skills/techniques.
•Knowledge in automation / IOT / Total Productive Maintenance (TPM) will have added advantage.
•Good understanding of MDSAP and ISO 13485 strongly preferred.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.