Manufacturing Quality Specialist

Job Description

Manufacturing Quality Specialist (QMS) – Biologics | Relocation Opportunity

We’re supporting a rapidly expanding biologics manufacturer through the next phase of its Chicago build-out, with continued investment across manufacturing capability, infrastructure and talent. We are seeking a Manufacturing QMS Specialist to strengthen the Quality function at a pivotal stage of that expansion.

This is a hands-on, manufacturing-facing Quality position responsible for writing and reviewing deviations, change controls, investigation reports, batch records, SOPs and CAPAs, working closely with both Upstream and Downstream Manufacturing.

The position requires a strong technical understanding of upstream and downstream biologics processes, including monoclonal antibody manufacturing, and would suit someone who genuinely understands Quality on the manufacturing floor within a GMP biologics environment.

Responsibilities

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• Support the Manufacturing team with deviations, change controls, CAPAs and investigation reports.
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• Write, review and drive manufacturing deviations and investigations through to closure, including root cause analysis using tools such as 5-Why and 6M.
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• Review executed Upstream and Downstream batch records and associated GMP manufacturing documentation.
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• Author, review and revise SOPs, batch records and other controlled manufacturing documents.
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• Partner closely with Upstream and Downstream Manufacturing to provide day-to-day Quality support and resolve GMP issues on the manufacturing floor.
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• Support the implementation and continuous improvement of the site's Quality Management System as manufacturing operations continue to scale.
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• Participate in cross-functional meetings and provide Quality input into manufacturing issues, investigations and process improvements.
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Qualifications

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• Bachelor's degree in Life Sciences, Biotechnology, Chemical Engineering or a related scientific discipline.
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• 3+ years of hands-on Quality experience within GMP biologics manufacturing.
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• Demonstrated experience with deviations, investigations, CAPAs, change controls, batch record review and SOPs.
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• Strong technical understanding of Upstream and Downstream biologics manufacturing processes.
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• Experience supporting mammalian cell culture and/or monoclonal antibody manufacturing strongly preferred.
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• Experience working directly with Manufacturing teams and providing Quality support on the manufacturing floor.
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• Strong understanding of GMP requirements and Quality Systems within a regulated biologics manufacturing environment.
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Please Note: These are full-time, on-site roles based in Chicago City.

Relocation assistance is available , and we welcome applications from candidates across the U.S. who are open to relocating.