Quality Control (QC) Specialist
Esco Lifesciences Group, is Singapore’s most globalized life
sciences company, with annual revenues close to SGD 200M and global operations
in over 20 countries across North America, Europe and Asia.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and
was first introduced in 2017.
At Esco Aster Pte Ltd, we are a contract development and
manufacturing organization founded and deeply rooted by scientists enabling
fellow scientists to translate their bench work into commercially available
products and services at affordable prices.
The work we do creates a remarkable and lasting impact on our
world. Join us as we redefine healthcare for the current and future generations
to come.
Esco Aster.
One World Biosolutions for One Health.
Physical/Mental Requirements/Work Environment
- Ability to understand protocols, technical reports and technology transfer documents.
- Ability to understand standard operating procedures and other related documents.
- Able to commit to weekend work when needed, off in lieu will be given for work on public holidays.
- Repetitive motions due to certain laboratory techniques.
- Good Understanding of Aseptic Techniques.
- Work performed in a clean room environment wearing PPE.
- Ability to define problems, collect data, establish facts and draw conclusions.
- Ability to focus regardless of circumstances and stress induced pressure.
- Ability to take proactive approach.
- Meticulous and systematic.
- Commitment to continuous learning and staying updated with industry best practices.
- Have strong focus on safety, quality and timeliness.
- Have strong critical thinking skills.
You will be part of Esco Aster's Quality Control team, comprising of Chemistry, Biochemistry and Microbiology laboratories, and contribute to the overall site mission and objectives. Specifically, you will contribute to microbial-related analytical testing and operational activities to ensure the compliance of site’s finished bio-products.
Primary
work location: Ayer Rajah Crescent, Singapore
Report to: Quality Manager
- Ensure proper calibration and maintenance of Quality Control (QC) equipment.
- Provide technical support and advice on QC matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
- Manage the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements.
- Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods or stability samples.
- Where applicable, Involve in Method development, Method Validation and Method Transfer for incoming consumables, raw materials & finished products.
- Perform QC testing on raw materials, intermediates, finished products, environmental monitoring and utilities.
- Complete QC testing in a timely manner in accordance with schedules, SOPs and workflows.
- Operate various analytical equipment and testing methods, including necessary troubleshooting.
- Evaluate, analyze and report on test data and results.
- Perform calibration and maintenance of QC laboratory equipment.
- Support/ perform QC laboratory equipment/system qualification.
- Support/ perform validation on testing method.
- Support in writing and maintenance of SOPs, workflows, reports, quality control criteria.
- Support procurement of QC laboratory supplies (reagents, consumables and others).
- Monitor and maintain suitable inventory level of QC laboratory supplies.
- Ensure proper record keeping and data management.
- Escalate issues and atypical events to Supervisor/Manager.
- Support/ perform laboratory investigation.
- Adhere to all site safety requirements.
- Perform all tasks in accordance with cGMP regulations.
- Undertake tasks assigned by leaders as and when appropriate.
- Degree or Diploma in Microbiology, Biotechnology, or related field.
- Minimum 2 years work experience in pharmaceutical/biopharmaceutical manufacturing preferred.
- Good understanding of GMP requirements in release testing.
- Knowledge and experience on QC laboratory operations and procedures, analytical test methods, troubleshooting and evaluation of analytical results.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Must be able to work in team as well as independently.
- Good communication skills and able to openly communicate and escalate any relevant issues.
- Will be able to commit 5 working days per week in a fixed pattern.
Apply now by submitting a Cover Letter and CV to [email protected].