Production Specialist

1 week ago


Cambridge, Cambridgeshire, United Kingdom SRG Full time

**Job Summary**

SRG is seeking a highly skilled Production Specialist to join our team in Cambridge. As a key member of our production team, you will be responsible for supporting the manufacture and quality control of specialist reagents.

**Key Responsibilities:**

  • Prepare reagents, lyophilise, and conduct quality control and production of small to medium-scale batches.
  • Handle receipt of reagents and chemicals, including aliquoting, storage, and uploading onto the Quality Management System (QMS) as necessary.
  • Collaborate with Contract Manufacturing Organisations (CMOs) and in-house specialists to support production scaling activities.
  • Create and implement quality control and validation protocols, ensuring adherence to regulatory processes.
  • Report quality control pass and fails, monitor non-conformance, and take corrective action.
  • Adhere to ISO 13485 and FDA regulations.
  • Maintain accurate records and document production activities in accordance with company policy.

**Requirements:**

  • Bachelor's degree in a biological discipline or related field.
  • Background in an In Vitro Diagnostic (IVD) development setting, working to ISO 13485 standards in a production or quality control team.
  • Proven industry or commercial laboratory experience, ideally in a device development setting.
  • Good proficiency with Real-Time Polymerase Chain Reaction (RT-PCR) and other molecular techniques.
  • Strong command of operating within a Quality Management System (QMS).
  • Excellent attention to detail, methodical approach, and ability to work in a fast-paced environment.
  • Strong communication and organisational skills, with the ability to collaborate effectively in a multidisciplinary team.


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