Quality Assurance Officer

Onyx Scientific are looking for a Quality Assurance Officer to join our fantastic QA team. At Onyx Scientific, we are a trusted partner to a cross section of academic, biotech and pharmaceutical clients across the world, providing cutting-edge services from discovery through to commercial manufacture.

As a fast-growing Contract Development and Manufacturing Organisation (CDMO), we are committed to scientific excellence, innovation, and delivering solutions that make a real difference to patients’ lives.

You will ideally have a degree which is analytical chemistry or chemistry based and have experience in most modern analytical techniques such as HPLC, GC, FT-IR, LC-MS and wet chemistry techniques.

Self-motivated and able to work with minimal supervision, you will have good interpersonal skills, both verbal and written, which are essential for working with both customers and colleagues. Working within the GMP and safety guidelines set by the company, you will assist the Quality Assurance Manager in ensuring the company Quality Management System (QMS) is maintained and complies with the requirements of Good Manufacturing Practice (GMP) as described in the current EU and ICH guidelines.

Key Responsibilities:

• QA reviews of PRS/PAR/logbooks/stability studies
• QA reviews of Reference standard packs
• Perform QA reviews of equipment qualification documents
• Basic understanding of ALCOA++, GDocP
• Perform visual inspection of equipment/area
• Issue of processing documentation
• Issue of logbooks, SOPs
• Perform generation of change controls and NCR’s
• Scanning/filing/logging activities (if required)
• Perform review of analytical data on Openlab 2.7 under supervision
• Review of EM data under supervision
• Review of Temperature mapping data under supervision.

Key Skills and Qualities:

• Basic understanding of cGMP, ICH, Eudralex Volume 4 Part II
• Able to demonstrate basic problem-solving skills and can identify potential issues
• Able to communicate appropriately and effectively with colleagues
• Good attention to detai
• Familiarity of analytical techniques (if appropriate), their applications, and roles within the company.
• Able to use initiative, multi-task and plan work effectively to meet strict deadlines
• A flexible approach to working additional hours when required
• Computer literate, familiar with Microsoft Word and Excel
• Work effectively as part of a team, showing resourcefulness and reliability
• Good organisational, interpersonal, and time management skills
• Enthusiastic, flexible, conscientious and proactive in approach
• Takes a positive approach to own training and development

What We Offer:

• A competitive salary, dependent upon skills and experience.
• Opportunities for career progression and ongoing professional development.
• The chance to work on diverse, high-impact client projects.
• A supportive, collaborative culture where your contributions are valued and recognised.

Benefits:

• Company events
• Cycle to work scheme
• Free on-site parking
• Health & wellbeing programme
• Life insurance
• Private medical insurance