Production Specialist

1 week ago

Cambridge, Cambridgeshire, United Kingdom SRG Full time

**Job Summary**

SRG is seeking a highly skilled Production Scientist to join our team in the manufacture and quality control of specialist reagents. As a key member of our production team, you will be responsible for preparing reagents, lyophilisation, and quality control, as well as supporting the production scaling activities.

**Key Responsibilities:**

  • **Reagent Preparation and Quality Control**: Prepare reagents, lyophilise, and conduct quality control to ensure high-quality products.
  • **Production Scaling**: Support the production scaling activities, working alongside Contract Manufacturing Organisations (CMOs) and in-house specialists.
  • **QC and Validation**: Create and implement quality control and validation protocols, ensuring compliance with regulatory processes.
  • **Reporting and Record-Keeping**: Report any quality control pass and fails, monitor non-conformance, and take corrective action. Maintain accurate records and document all production activities in accordance with company policy.
  • **Regulatory Compliance**: Adhere to all ISO 13485/FDA regulations and follow Standard Operating Procedures (SOPs).

**Requirements:**

  • **Education**: BSc or equivalent in a Biological discipline (or related).
  • **Experience**: Background in an In Vitro Diagnostics (IVD) development setting, working to ISO 13485 standards in a production or quality control team.
  • **Skills**: Proven industry/commercial lab experience, ideally in a device development setting. Good proficiency with Real-Time Polymerase Chain Reaction (RT-PCR) and other molecular skills. Strong command of operating within a Quality Management System (QMS).
  • **Personal Qualities**: Exemplary attention to detail, methodical approach, and ability to work in a busy and demanding environment. Strong communication and organisational skills, with the ability to collaborate well within a multidisciplinary team.

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