Microbiology Data Reviewer: GMP Investigations & CAPAs

5G-Starlink Pte.; Singapore; On-site; SGD 109,000 - 154,000; Full time

Job summary

5G-Starlink Pte. in Raleigh, NC is seeking a Microbiology Data Reviewer to join our pharmaceutical team onsite.

The role focuses on microbiology data review of both paper records and select digital sources, ensuring data integrity and compliance with SOPs. The successful candidate will perform investigations related to environmental monitoring excursions, non‑compliance events, and general OOS/OAL cases, while coordinating CAPAs with Microbiology management.

Qualifications

• Microbiology data review experience in pharma/GMP environments.
• Experience authoring laboratory investigations and CAPAs.
• Familiarity with cGMP, GLP and FDA requirements.
• Technical degree in a scientific discipline required.

Responsibilities

• Conduct microbiology investigations of environmental monitoring excursions and non‑compliance with procedures.
• Review GMP/GDP data and accompanying write-ups; update procedures with Microbiology management.
• Ensure data integrity and adherence to test methods and SOPs throughout the review process.
• Assist in developing and executing robust CAPAs based on investigation outcomes.
• Ensure timely initiation and closure of investigations to meet internal requirements.

Skills

Microbiology knowledge

Data review

Investigations writing

Quality/compliance mindset

Education

BS/BA in scientific discipline

Tools

Kinetic LAL

Gel-clot LAL

Filtration & aseptic technique

Particulate testing

Job description

5G-Starlink Pte. in Raleigh, NC is seeking a Microbiology Data Reviewer to join our pharmaceutical team onsite.

The role focuses on microbiology data review of both paper records and select digital sources, ensuring data integrity and compliance with SOPs. The successful candidate will perform investigations related to environmental monitoring excursions, non‑compliance events, and general OOS/OAL cases, while coordinating CAPAs with Microbiology management.