Technologist, QA Specialist - Analyst​/Manager, Quality Control - QC Analysts​/Managers

Reference no
:
R2867889

Position title:Technologist

Duration: Fixed Term Contract
-11.5 months

Location:Toronto, ON

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well‑being.

At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting‑edge science and manufacturing,fueledby data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

We’rean R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

1. Coordinates and performs routine standard testing.

• Responsible for coordinating and performing assigned routine immunochemical and instrumental assays within a team environment in accordance with existing SOPs (e.g. ELISAs, cell‑based assays, SDS-PAGE/Densitometry, identity by Western Blot/Dot Blot/LC-MS/FTIR; HPLC, IC, GC, UV‑VIS,TOC, Osmometry).

• Responsible for daily maintenance of test related equipment and system suitability, as required. Ensures that deaning procedures, calibration and or validation of equipment meets testing requirements, alerts others if issues arise. (ELISA plate washers/ readers, LC-MS and Chromatography systems, Densitometer, UV‑VIS, FTIR, Biosafety cabinets, pipettes, balances, pH and Conductivity meters and weight sets.)

• Responsible for coordinating and performing routine in‑house wet chemistry tests on in‑process materials or final products (e.g. Nitrogen determination by micro‑Kjeldahl, Aluminum by complexometric titration, identity by TLC).

• Perform wet chemistry/identity testing on Raw Materials according to in‑house SOPs and Pharmacopoeias

• Assist with troubleshooting of invalid/unexpected results.

• Perform qualification of critical reagents according to SOPs, as required.

• Responsible for test reagent maintenance, inventory and supply and to ensure reagent supplies are replenished in a timely manner to avoid testing delays.

2. Documentation Testing and Support Documents.

• Responsible for the timely and accurate completion and verification of test related documents to ensure on time delivery of test results. (e.g. data in LIMS, worksheets, log books, test requisitions, verification of calculations for accuracy, verification of entries and transcription of data, review of electronic data including audit trails, as applicable).

• Manage samples outsourced to approved contract labs including documentation preparation (Test Request and Shipping Form), review of test results (Certificates) from contract labs and transcription of results into LIMS or internal QC release documents, as required.

• Responsible for ensuring testing SOPs are accurate and reflect current testing procedures.

• Review existing SOPs & initiate revisions or writing of SOPs, responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.

• Contribute to protocols, reports and test summaries as required. (e.g. Qualification of critical reagents reagents, test transfers, test method validations).

• Responsible for updating and maintaining trending data as required. (e.g. trending of test standards and controls).

• Responsible for accurately compiling data for tests and products, for statistical reports, investigations, regulatory questions and or submissions as required.

• Responsible for ensuring accuracy of critical reagent inventory as related to responsibility.

• Responsible for management of documents…