Quality Control Associate

VELA OPERATIONS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A biotechnology company in Singapore seeks a dedicated Quality Control Specialist. Responsibilities include performing quality control tests, ensuring compliance with regulations, and conducting stability studies. The ideal candidate holds a degree in Life Sciences and possesses strong organizational and problem-solving skills. Experience in molecular biology techniques is preferred. This role offers a dynamic environment for growth and collaboration.

Qualifications

• 0 - 2 years of QC working experience in a quality control function or minimum of 2 years of relevant experience.
• Experience with general molecular biology techniques and real-time PCR.
• Knowledge of USFDA, ISO9001:2000, ISO13485, GMP, and GLP standards.

Responsibilities

• Perform QC activities for incoming materials and finished goods.
• Carry out inspection and lab tests according to procedures.
• Monitor and summarize QC results as required.

Skills

General molecular biology techniques

Real-time PCR

Nucleic acid extraction

Next Generation Sequencing technologies

Strong organizational skills

Strong interpersonal skills

Problem-solving skills

Attention to detail

Education

Bachelor’s Degree or diploma in Life Sciences

Tools

MAC OS

Microsoft Office applications

Job description

Job Summary

This position is part of the team that performs quality control testing of products via various molecular and quality testing techniques. Activities conducted would be required to comply with applicable company and regulatory requirements.

Duties & Responsibilities

1. Perform activities related to quality control (QC) of incoming materials, in-process products, and finished goods to support the manufacturing schedule.
2. Carry out inspection and lab test of raw materials, sub-assemblies, finished products according to stipulated procedures.
3. Perform stability study for finished products.
4. Perform routine lab maintenance, material inventory management, and purchasing duties.
5. Co-operate with production activities including performing production tasks.
6. Conduct the disposition of suspected non-conforming materials and products.
7. Authoring QC work instruction, lab report form, and other SOPs as required.
8. Monitoring and summarizing QC results as required.
9. Authoring nonconformance reports, deviation reports, change control, and other documentation as required.
10. Undertake root cause analysis activity on non-conforming incident/excursion. Recommend and implement corrective and preventive action.
11. Support and participate in internal and external audits.
12. Perform qualification and technical selection of QC equipment. Involve in method transfer and validation.
13. Collaborate with cross-function team (e.g. Production, R&D, Supply Chain, and Quality Assurance) on product transfer projects.

Job Requirements & Attributes

• Bachelor’s Degree or diploma in Life Sciences (Biotechnology, Biomedical Science, Biochemistry, Life Science or related).
• 0 - 2-year Q C of working experience in a quality control function or minimum of 2 years of industrial / research experience in a biotechnology/medical device/pharmaceutical manufacturing industry.
• Experience with general molecular biology techniques, including real-time PCR, nucleic acid extraction, and quantitation.
• Experience with Next Generation Sequencing technologies will be a plus.
• Knowledge in areas related to USFDA, ISO9001: 2000, ISO13485, Good Manufacturing Practices (GMP), and Good Laboratory (GLP) or other international standards.
• Strong organizational and record-keeping skills, high attention to detail, ability to multi-task with aggressive timelines and meticulous in work.
• Strong interpersonal and team skills, ability to communicate and manage well at all levels of the organization.
• Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses; strong desire to learn, adapt and advance in a fast-growing environment.
• High level of integrity and dependability with a strong sense of urgency and results-oriented; willing to put extra effort to drive the process and achieve the goal.
• Knowledge of MAC OS and Microsoft office applications.