Quality & Regulatory

QA Document Control Specialist Direct Hire MA

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Job ID: 15111 Direct Hire MA

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Our client is a well-funded, clinical-stage biotech startup looking for an experienced QA documentation specialist/lead to join their team in the Boston area! This is a full time, permanent position and is a great opportunity to join a growing, tight-knit company.

This hands-on role will focus on QA document control, mostly in CMC, and support their quality team. You will be responsible for spearheading document control initiatives (GLP, GMP, GCP) and ensure compliance to regulations, SOPs, specifications, and other criteria. This includes issuing, maintaining, archiving, and retiring documents and working with external subcontractors, as well as vendor oversight and lot release.

A formal description can be supplied for interested candidates.

Qualified candidates will have demonstrated experience in QA and/or document control, good documentation practices (GDP), and knowledge of quality systems. An Associate's degree or higher is preferred.  

Must be authorized to work in the US indefinitely to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.