Quality Assurance Officer
đ Onyx Scientific | Quality Assurance | Pharmaceutical CDMO
Onyx Scientific is looking for a Quality Assurance Officer to join our collaborative and growing Quality Assurance team.
We are a trusted partner to academic, biotech, and pharmaceutical organisations worldwide, delivering services from early discovery through to commercial manufacture. As a leading Contract Development and Manufacturing Organisation (CDMO), we are committed to scientific excellence, innovation, and delivering solutions that improve patientsâ lives.
This is a great opportunity for someone with a scientific background and an interest in Quality Assurance and GMP environments to develop their career within a supportive and innovative organisation.
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The Role
Working within GMP and company safety guidelines, you will support the Quality Assurance Manager in maintaining and improving our Quality Management System (QMS) while ensuring compliance with EU GMP and ICH regulatory requirements.
You will work closely with colleagues across analytical, production, and technical teams, helping ensure that our processes, documentation, and systems meet the highest quality standards.
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Key Responsibilities
* QA review of PRS, PAR, logbooks, and stability studies
* QA review of reference standard documentation
* Review equipment qualification documentation
* Perform visual inspection of equipment and operational areas
* Issue processing documentation, logbooks, and SOPs
* Generate and manage Change Controls and Non-Conformance Reports (NCRs)
* Support document control activities (scanning, filing, logging when required)
* Review analytical data in OpenLab 2.7 (under supervision)
* Review environmental monitoring (EM) and temperature data (under supervision)
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About You
We are looking for someone who is detail-oriented, organised, and motivated to work in a quality-focused scientific environment.
Essential / Preferred:
* Degree in Analytical Chemistry, Chemistry, or a related scientific discipline
* Familiarity with analytical techniques such as HPLC, GC, FT-IR, LC-MS, and wet chemistry methods
* Basic understanding of cGMP, ICH guidelines, and EudraLex Volume 4 Part II
* Awareness of ALCOA++ and Good Documentation Practice (GDocP)
* Strong attention to detail and documentation accuracy
* Good communication and teamwork skills
* Ability to prioritise work and meet deadlines
Weâre particularly interested in candidates who are proactive, eager to learn, and committed to continuous professional development.
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What We Offer
âš Competitive salary (dependent on experience)
đ Career development and training opportunities
đ§Ș The chance to work on diverse, high-impact pharmaceutical projects
đ€ A supportive and collaborative culture where your work makes a difference
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Benefits
* Private medical insurance
* Life insurance
* Health & wellbeing programme
* Cycle to work scheme
* Free on-site parking
* Company events
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đ If youâre passionate about quality, science, and making an impact in pharmaceutical development, weâd love to hear from you.
Apply today or connect with us to learn more about opportunities at Onyx Scientific.