Quality Assurance Associate
deciphex · Dublin
Job description
About the role
We’re looking for a Quality Associate to own document control and training administration across the business and to help us get the most out of a brand‑new quality management system.
Key responsibilities
- Own the electronic document control process, the document register, the document control mailbox, and the document library structure.
- Administer the eQMS (Greenlight Guru): become the in‑house expert on its functions and workflows, and train colleagues on how to use it.
- Manage the training system, onboarding and off‑boarding, assigning and tracking training, chasing outstanding records, and keeping training files complete.
- Run the process for creating new controlled documents and for periodic document review.
- Prepare and review controlled documents for formatting and accuracy, and process GxP documents for e‑signature.
- Manage physical documentation in the Dublin office, receiving, filing and archiving records, including materials sent from other sites.
- Support customer and regulatory audits, gathering and presenting documentation, acting as scribe or runner, and assisting the QA host.
- Maintain the supplier register and keep supplier certification current.
- Record and report KPIs for document control, training and other quality processes.
- Provide back‑up support on CAPA, deviation and change management.
- Support Deciphex sites in the UK, US and elsewhere as needed.
Required profile
- A qualification (certificate, diploma or degree) in a life‑science, IT or related discipline.
- 2+ years’ experience in a document control, training administration, QA or quality systems role within a regulated life‑science environment.
- Hands‑on experience administering an electronic quality or document management system.
- Adaptability – no two days look the same.
- Strong communication and relationship‑building skills.
- Ability to organise and prioritise own workload with support.
- Diligence and attention to detail when reviewing documents.
Required skills
- Electronic quality management system (eQMS) administration.
- Experience with Greenlight Guru or a comparable eQMS.
What we offer
- Healthcare benefits.
- Competitive annual leave.
- A true sense of meaning in your work by contributing to better patient outcomes.
- Opportunity to work alongside a world‑class high‑performing team in a hyper‑growth startup environment.
- Exciting, challenging and unique projects.
- Regular performance feedback and significant career growth opportunities.
- A highly collaborative and supportive multicultural team.
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Published 5 days ago
Expires 1 month from now
20 views · 0 interested
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deciphex
Dublin