Senior Laboratory Officers Quality Control

Consortium for Clinical Research and Innovation, Singapore; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization in Singapore is seeking a QC Laboratory Officer. The role involves performing quality control activities in compliance with GMP guidelines and includes responsibilities such as cleanroom activities, equipment maintenance, and documentation. Candidates should hold a degree in Life Sciences and possess experience with QC techniques. A strong emphasis is placed on attention to detail and team collaboration. The position offers a renewable 3-year contract.

Qualifications

• Prior experience with QC techniques in GMP cleanroom is advantageous.
• Attention to detail and strong analytical thinking skills are required.
• Aseptic gowning and ability to work long hours in a GMP cleanroom.

Responsibilities

• Perform QC related activities in compliance with SOP and GMP guidelines.
• Responsible for maintenance and documentation of cleanroom activities.
• Conduct QC in-process and final product testing and analysis independently.

Skills

QC techniques

Cell culture

Analytical thinking

Team player

Communication skills

Education

Degree / Diploma in Life Sciences

Microbiology

Chemistry

Tools

Flow cytometry (FACSLyric, MACSQuant)

ELISA testing (Tecan)

RT-PCR (Quantstudio)

Job description

Overview

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future‑ready healthcare system.

Business Entities under CRIS

• Singapore Clinical Research Institute (SCRI)
• National Health Innovation Centre (NHIC)
• Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
• Precision Health Research, Singapore (PRECISE)
• Singapore Translational Cancer Consortium (STCC)
• Cardiovascular Disease National Collaborative Enterprise (CADENCE)
• Singapore Medical Foundation AI model (SIMFONI)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you!

ACTRIS

The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life‑threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular‑based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value‑added services such as workforce training, regulatory facilitation and ancillary material standardisation, pertaining to delivery of cellular therapy to patients.

What you will be working on

The QC Laboratory Officer shall perform CTGTP QC related activities in compliance with ACTRIS SOP and relevant GMP and Safety guidelines.

• Perform cell therapy manufacturing related procedures in compliance with regulatory, GMP and safety guidelines
• Responsible for all aspects of cleanroom activities such as inventory planning, environmental monitoring and facility/equipment sanitisation with a GMP manufacturing setting
• Ensure proper maintenance and control of manufacturing areas, clean suites and equipment
• Responsible for accurate and timely documentation of relevant batch records, forms and log sheets for the tasks performed in compliance with GDDP (Good Data and Documentation Practices)
• Resolve operational issues and escalate when required
• Support root cause analysis, CAPA, OOS, OOT, deviations, and change controls
• Participate in technology transfer and other cross‑function projects
• Participate in environmental monitoring, microbiological assessment, materials and/or equipment including developing URS, SOPs and providing training related to laboratory methods and/or equipment
• Check equipment PM/service reports, IOQ documents and ensure completeness and GDDP compliance
• Assist in the SLO review of documents such as PM, IOQ documents, QC test reports and log sheets
• Draft and execute PQ for new QC equipment
• Support / manage QC Lab inventory to ensure a continuous supply of consumables for the required testing procedure
• Support / manage QC Lab equipment to ensure it is qualified, validated and well maintained for the required testing procedure
• Identify processing gaps, participate or contribute to the team (researcher, cell specialist and project team) in development of new or improvement of existing laboratory test methodologies/instrumentation
• Maintain good filing system for documentation including equipment, inventory, raw data, test records, deviation reports, validation records etc.
• Perform QC in‑process and final product testing and analysis independently
• Other duties and responsibilities as assigned by the RO or HOD

What we are looking for

• Degree / Diploma in Life Sciences, Microbiology, Chemistry
• Prior experience with QC techniques such as cell culture, cell count (Sysmex), flow cytometry (FACSLyric, MACSQuant), ELISA testing (Tecan), RT‑PCR (Quantstudio), potency, microbiology and/or working in GMP cleanroom will be an advantage
• Attention to detail and possess analytical thinking skill
• Able to be a team player with good communication skills and strong team‑orientated work ethic
• Able to perform aseptic gowning and work in GMP cleanroom for long hours
• Proficient in English

What you need to know

Successful candidate will be offered a 3‑year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below.

• CRIS – https://www.cris.sg
• SCRI – https://www.scri.edu.sg
• NHIC – https://www.nhic.sg
• ACTRIS – https://www.actris.sg
• PRECISE – https://www.npm.sg
• STCC – https://www.stcc.sg
• CADENCE – https://www.cris.sg/our-programmes/cadence/