Job Description

At ALS, we encourage you to dream big.

When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future.

• Review the generated raw data, worksheets, calculations, and test records related to bioassay and immunogenicity for accuracy and completeness.
• Verify compliance with approved SOPs, protocols, specifications, and applicable regulatory guidelines.
• Review test reports, certificates of analysis, and results before release.
• Ensure adherence to ALCOA+ data integrity principles and GMP/GLP requirements.
• Review deviations, OOS (Out of Specification), OOT (Out of Trend), incidents, and change controls related to bioassay activities.
• Assess CAPA effectiveness and ensure timely closure of quality events.
• Review instrument qualification, calibration, maintenance, and logbook records.
• Review project audit trails with respect to instruments like plate reader, Flow cytometer, Luminex.
• Verify analyst training, qualification, and competency records.
• Prepare compliance trends.
• Maintain QA review records and ensure timely archival of documents.
• Conduct computerized system and data integrity risk assessments.
• Participate in investigation and remediation of data integrity incidents and audit observations.
• Coordinate with all the cross functional teams for successful project execution

Working at ALS

The ALS team is a diverse and dedicated community united by our passion to make a difference in the world.

Our values are important to us, and shape how we work, how we treat each other and how we recognise excellence.

At ALS, you’ll be supported to develop new skills and reach your full potential. We invest in our people with programs and opportunities that help you build a diverse career with us.

We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and our communities.

Everyone Matters

ALS is proud to be an equal opportunity employer and is committed to fostering an inclusive work environment where the strengths and perspectives of each employee are both recognised and valued.

ALS also welcomes applications from people with all levels of ability. Reasonable adjustments to support candidates throughout the recruitment process are available upon request. 

Eligibility

To be eligible to work at ALS you must be a Citizen or Permanent Resident of the country you are applying for, or either hold or be able to obtain, a valid working visa.

How to apply

Please apply on-line and provide a resume & cover letter that best demonstrate your motivation and ability to meet the requirements of this role.