QA Associate I

4 days ago

Tuas, Singapore Amgen Full time

Career Category

Quality

**Job Description**:
Role Description

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Responsible for providing oversight for Quality on-the-floor and operations support, the Associate QA will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (rotational night and day, or full night shift as required due to business needs).

**Responsibilities**:

- Support the maturation and continuous improvement of Amgen quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
- Participate in on the floor triage and support root cause investigations for major investigation if applicable.
- Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
- Support in regulatory inspections, and interact directly with regulatory inspectors
- Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
- Escalate any significant event to Quality management in a timely manner

Basic Qualifications
- Bachelor’s Degree in Science and 2 years of directly related experience OR
- Associate’s degree in Science and 4 years of directly related experience OR
- High school diploma/GED in Science and 6 years of directly related experience

Preferred Qualifications
- Fluency in written and spoken English
- 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.
- Direct experience with bulk manufacturing of biopharmaceuticals preferred.
- Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

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