Job Scope and Purpose:
Our client, a growing small biotech company in Cambridge, is looking for a Quality Systems Sr. Specialist/Manager with a few years of experience to join their team. This company has outstanding internal culture so if you come from a document control background, can learn quickly, and like to work with outgoing people in a fast paced environment then please apply!
Primary Job Responsibilities:
Learn, help develop, and manage GMP quality systems and be a champion of QMS electronic documentation
Perform internal audits, track deviations, change controls, and CAPAs, and assess gaps in inspection readiness
Work with external CMOs and track data and documentation in accordance with the internal electronic data system
Primary Job Requirements:
BS with 2-5 years direct experience in a QA or document setting in the pharmaceutical industry
Strong understanding of cGMP, FDA, EU, and ICH requirements
Ability to manage multiple projects at a time and communicate effectively with a matrixed internal team
Smile at work – this is a fun company to be in!
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