QA Associate (Biotechnology/Tuas/1 Year Contract/Up to $4000)
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 include:
- Support the maturation and continuous improvement of 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 or related technological field and 2 years of directly related experience OR
- Associate’s Degree in Science or related technological field and 4 years of directly related experience OR
- High School Diploma in Science or related technological field / GED and 6 years of directly related experience
Preferred Qualifications
- 1-3 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
EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao
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