Manufacturing Quality Specialist
Manufacturing Quality Specialist
global life science hubMemphis, TN
yesterday
Biological Product (except Diagnostic) ManufacturingPharmaceutical Preparation ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)
Apply for this role →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:
Support the Manufacturing team with deviations, change controls, CAPAs and investigation reports. Write, review and drive manufacturing deviations and investigations through to closure, including root cause analysis using tools such as 5-Why and 6M.Review executed Upstream and Downstream batch records and associated GMP manufacturing documentation. Author, review and revise SOPs, batch records and other controlled manufacturing documents. Partner closely with Upstream and Downstream Manufacturing to provide day-to-day Quality support and resolve GMP issues on the manufacturing floor. Support the implementation and continuous improvement of the site's Quality Management System as manufacturing operations continue to scale. Participate in cross-functional meetings and provide Quality input into manufacturing issues, investigations and process improvements.
Qualifications:
Bachelor's degree in Life Sciences, Biotechnology, Chemical Engineering or a related scientific discipline.3+ years of hands-on Quality experience within GMP biologics manufacturing. Demonstrated experience with deviations, investigations, CAPAs, change controls, batch record review and SOPs. Strong technical understanding of Upstream and Downstream biologics manufacturing processes. Experience supporting mammalian cell culture and/or monoclonal antibody manufacturing strongly preferred. Experience working directly with Manufacturing teams and providing Quality support on the manufacturing floor. Strong understanding of GMP requirements and Quality Systems within a regulated biologics manufacturing environment.
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.
Also on the board Same function, level within a rung
Level
Senior
Location
Memphis, TN
Occupation
Quality Control Systems Managers
Industry
Biological Product (except Diagnostic) Manufacturing
Posted
yesterday