Microbiology Data Reviewer

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

About the job Microbiology Data Reviewer

• AMAZING OPPORTUNITY to join a great PHARMACUTICAL TEAM working ONSITE in Raleigh, NC!!!*
• Amazing opportunity to join a growing Pharmaceutical company working as a Data Review working with their paper records and some digital. Must have a Microbiology based experience to be able to preform these duties!!!* ****MUST BE OPEN TO WORKING 2nd/3rd SHIFT!!!****
• MUST HAVE:* *
• Microbiology experience and microbiology data review needed for their process/SOP* *
• Technical Degree (BS/BA in a Scientific Discipline)* *
• 7-10 years of Pharmaceutical/GMP environmental experience* *
• Previous investigation writing and auditing experience* *
• Knowledge of cGMP, GLP and FDA requirements* *
• SKILLS:* *
• Kinetic LAL and Gel-clot LAL* *
• Filtration and Aseptic Technique* *
• Particulate Testing* *
• Description:*
• Will be responsible for conducting Microbiology investigations of varying degrees (environmental monitoring excursions, non-compliance with procedures, general OOS/OAL for microbiology testing and executing subsequent corrective actions as deemed necessary based on findings of investigations).
• Will also be responsible for conducting GMP/GDP data review of laboratory analyses and associated write-up documentation as well as updating of documents and procedures in coordination with Microbiology management.
• Will ensure the analysts adherence to test methods, SOPs, etc. when reviewing data, and that data integrity was maintained throughout the testing process.
• Will assist in development and execution of robust CAPAs based on outcomes of investigation will be within the scope of this position.
• Will ensure Timely initiation and closure of all investigations will be expected to ensure that compliance with internal requirements are met.
• Additional Skills & Qualifications:*
• Prefer Technical / sciences based degree
• Experience with authoring Lab investigations in relation to environmental monitoring excursions, non-compliance with procedures, and general OOS/OAL investigations.
• Determining and executing corrective actions stemming from investigations
• Review of data, data entry, reporting and logbooks.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.