Onyx Scientific
Quality Assurance Officer
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Quality Assurance Officer
📍 Onyx Scientific | Pharmaceutical CDMO | Location: Sunderland | Full-time | Permanent
Are you passionate about quality, compliance, and continuous improvement within a GMP-regulated environment?
At Onyx Scientific, we partner with academic, biotech, and pharmaceutical organisations worldwide, providing high-quality scientific support from early discovery through to commercial manufacture.
Due to continued growth, we're looking for a Quality Assurance Officer to join our Quality team and play a key role in maintaining compliance, supporting quality systems, and ensuring the highest standards across our operations.
The Role
As a Quality Assurance Officer, you will support the Quality Assurance Manager in maintaining and continuously improving the Quality Management System (QMS). Working in line with GMP requirements and company procedures, you will help ensure compliance across manufacturing, analytical, and support functions while contributing to the delivery of high-quality products and services.
Key Responsibilities
- Perform QA reviews of production records, analytical records, logbooks, and stability studies
- Conduct QA reviews of reference standard documentation packs
- Review equipment qualification and validation documentation
- Carry out routine inspections of facilities, equipment, and GMP areas
- Issue controlled documents including processing records, SOPs, and logbooks
- Support the generation and management of change controls, deviations, and non-conformance reports (NCRs)
- Maintain filing, scanning, archiving, and document control activities as required
- Review environmental monitoring and temperature monitoring records
- Comply fully with company SOPs, GMP requirements, and training obligations
- Carry out internal audits
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About You
We're looking for an enthusiastic and detail-oriented quality professional who thrives in a structured and regulated environment.
You'll be committed to maintaining high-quality standards, ensuring compliance with GMP requirements, and completing documentation accurately and efficiently. You'll be comfortable working independently while also collaborating with colleagues across multiple departments to support quality and business objectives.
Essential Skills and Experience
- Basic understanding of GMP, ICH guidelines, and EU GMP (EudraLex Volume 4)
- Knowledge of ALCOA++ principles and Good Documentation Practices (GDocP)
- Excellent attention to detail and a commitment to data integrity
- Strong organisational and time-management skills
- Effective communication and interpersonal skills
- Commitment to Health, Safety, Quality, and Environmental requirements
- Ability to follow procedures accurately and work within regulated quality systems
Desirable Skills and Experience
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- Degree in Chemistry, Analytical Chemistry, or a related scientific discipline
- Experience working within a GMP-regulated pharmaceutical environment
- Exposure to Quality Management Systems (QMS)
- Experience reviewing GMP documentation and records
- Familiarity with change control, deviation, and CAPA processes
- Knowledge of analytical techniques and laboratory quality systems
What You'll Bring
- A proactive and self-motivated approach
- A quality-focused and compliance-driven mindset
- Problem-solving ability and a continuous improvement approach
- Flexibility and adaptability to meet business requirements
- A collaborative attitude and willingness to support colleagues across teams
- A positive and enthusiastic approach to personal development and team success
What We Offer
✅ The opportunity to contribute to the delivery of high-quality pharmaceutical products
🤝 A supportive and collaborative quality-focused environment
📈 Career development within a growing pharmaceutical CDMO
Benefits
✨ Company events
🚲 Cycle to work scheme
🧠 Health & wellbeing programme
🛡 Life insurance
🏥 Private medical insurance
🚗 Free on-site parking
👉 If you're passionate about quality and compliance and want to make a meaningful contribution within a collaborative GMP environment, we'd love to hear from you.
Apply today to join the Onyx Scientific team.
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