QA Specialist II

We are seeking a QA Specialist II to support Quality Operations at a biologics manufacturing facility in Singapore. This is a 6-month renewable contract, working onsite Monday to Friday, 8:00 am–5:00 pm. Target onboarding is 19 October 2026.

The role provides day-to-day quality oversight of manufacturing activities to ensure compliance with GMP, approved SOPs and site quality standards.

Responsibilities:

• Review incoming materials for release, including Certificates of Analysis, supplier documents, and receipt and inspection records.
• Review SOPs, work instructions, executed batch records and other GMP documents for accuracy, completeness and compliance.
• Support QC activities and check associated records for data integrity.
• Participate in discussions of deviations and quality events, including impact assessments, investigations and CAPA follow-up.
• Work with Manufacturing, QC, Warehouse and Engineering to resolve quality issues and maintain inspection readiness.
• Support audits, regulatory inspections and continuous improvement activities as required.

Requirements

• At least 2–3 years of relevant experience in a GMP-regulated environment; pharmaceutical or biopharmaceutical experience is preferred.
• Working knowledge of biologics and cell culture bioprocessing, with some Quality Operations or on-the-floor QA experience.
• Experience with GMP document and SOP review, incoming material release, deviation management and batch record review. Electronic batch record experience is an advantage.
• Understanding of data integrity principles and good documentation practices.
• Diploma or degree in Life Sciences, Biotechnology, Chemistry, Pharmaceutical Science or a related discipline. A degree is not required.
• Strong attention to detail and communication skills, with the ability to work across teams and contribute quickly in a manufacturing environment.