M&S_Quality Control Analyst

Pharmaceuticals

M&S_QualityControlAnalyst-IFB

$145–215k ~AI est. Beijing, China FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“M&S_Quality Control Analyst - IFB at M&S_Quality Control Analyst. Skills: Quality Control, Analytical testing, GMP compliance. Participate in QC laboratory establishment. Participate in QC laboratory qualification”

Industry & Context.

Pharmaceuticals
Problems you'll solve

Troubleshooting; Investigating analytical issues; Problem-solving

What They're Looking For.

Must Have

Associate degree minimum, 2+ years industry experience, GMP knowledge required, Regulatory requirements knowledge

Nice to Have

Bachelor's degree or above, In-process control analysis experience, Equipment qualification experience, Method validation experience, Method verification experience, Method transfer experience

What You'll Do.

Participate in QC laboratory establishment

Participate in QC laboratory qualification

Participate in QC laboratory commissioning

Implement chemical tests

Implement chemical-physical tests

Implement bioanalytical tests

Perform DS release testing

Perform incoming material release testing

Perform in-process controls

Perform clean utility monitoring

Perform cleaning validation

Support analytical method transfers

Support validation activities

Execute analytical testing

Adhere to scheduled plans

Perform QC data review

Document measurement results

Document calculations

Prepare laboratory specifications

Review laboratory specifications

Prepare laboratory methods

Review laboratory methods

Prepare laboratory procedures

Review laboratory procedures

Implement device requalifications

Perform equipment calibration

Perform equipment maintenance

Coordinate equipment calibration

Coordinate equipment maintenance

Assist in troubleshooting

Assist in investigating analytical issues

Manage reagent stocks

Manage reference standard stocks

Perform tasks per cGMP

Perform tasks per HSE

Inform manager of quality events

Inform manager of HSE events

Execute assigned CAPAs

Execute remediation plans

Execute continuous improvements

Execute assigned works

How You'll Work.

Team & Collaboration

Cross-functional program organization; Q-functions collaboration

Process & Methodology

TIER 1 program lifecycle

Full Job Description

About the job Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China (IFB). For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing. Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. [_Watch now!_](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.douyin.com%2Fuser%2FMS4wLjABAAAAD1va6zT5_jjCchcfhkayLNl8dXAdtWcg-3fhgpGDjZk%3Fmodal_id%3D7477419452397587727%26relation%3D0%26vid%3D7358336359246892307&data=05%7C02%7CLucia.Kong%40sanofi.com%7C576b61229b4e4f39f75208dd5a3fd313%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638765952344347098%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WRX%2BePMJSyZXdpk0Kn9Qj23MYT0sFprEhZ8%2Bd%2BDsxtw%3D&reserved=0) _**Position Overview**_ The Quality Control Analyst will contribute to the execution of IFF IPC laboratory topics of the TIER 1 program lifecycle from feasibility to PPQ (Process Performance Qualification) including final approval. This role will work on establishing laboratory activities as qualification of equipment, transfer of analytical methods in QC in the InsuLINK project at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will support to develop procedures and documents and to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications. In addition to p

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