Quality Assurance Officer

2 weeks ago

Sunderland, Sunderland, United Kingdom Onyx Scientific Full time £40,000 - £60,000 per year

Quality Assurance Officer – Onyx Scientific

Onyx Scientific is seeking a
Quality Assurance Officer
to join our fantastic QA team.

We are a trusted partner to academic, biotech, and pharmaceutical organisations worldwide, providing cutting-edge services from discovery through to commercial manufacture. As a leading CDMO, we are committed to scientific excellence, innovation, and delivering solutions that make a real impact on patients' lives.

You'll ideally hold a degree in
analytical chemistry, chemistry, or a related field
, with experience in modern analytical techniques including
HPLC, GC, FT-IR, LC-MS
and wet chemistry methods.

You're self-motivated, able to work with minimal supervision, and an effective communicator who can build strong working relationships with colleagues and clients.

Working within GMP and company safety guidelines, you'll support the Quality Assurance Manager in maintaining and continuously improving our
Quality Management System (QMS)
, ensuring compliance with
EU and ICH GMP
requirements.

If you're passionate about quality and want to contribute to meaningful scientific work in a collaborative environment, we'd love to hear from you.

Key Responsibilities

  • QA reviews of PRS/PAR/logbooks/stability studies
  • QA reviews of Reference standard packs
  • Perform QA reviews of equipment qualification documents
  • Perform visual inspection of equipment/area
  • Issue of processing documentation, logbooks and 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 and temperature under supervision

Key Skills and Qualities

  • Basic understanding of cGMP, ICH, Eudralex Volume 4 Part II
  • Basic understanding of ALCOA++, GDocP
  • Can identify potential issues and able to demonstrate basic problem-solving skills
  • Able to communicate appropriately and effectively with colleagues
  • Good attention to detail
  • 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
  • Work effectively as part of a team, showing resourcefulness and reliability
  • 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

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