Scientific Production Specialist
4 weeks ago
Job Title: Scientific Production Specialist
Job Summary:
We are seeking a highly skilled Scientific Production Specialist to join our team at SRG. As a key member of our production team, you will be responsible for the manufacture and quality control of specialist reagents.
Key Responsibilities:
- Preparation of reagents, lyophilisation and quality control of small-medium scale batches.
- Handling receipt of reagents and chemicals, including aliquoting, storage and uploading onto the QMS as necessary.
- Working alongside CMO's and in-house specialists to support the production scaling activities.
- Create and implement QC and validation protocols, ensuring that regulatory processes are followed meticulously.
- Report any QC pass and fails, monitoring any non-conformance closely and taking corrective action.
- Strictly adhere to all ISO 13485/FDA regulations.
- Follow SOP's, maintaining accurate records and document all production activities in accordance with company policy.
Requirements:
- BSc or equivalent in a Biological discipline (or related).
- Background in an IVD development setting, working to ISO 13485 standards in a production or QC team.
- Proven industry/commercial lab experience, ideally where there are devices in development.
- Good proficiency with RT-PCR along with other classic molecular skills such as reagent and/or chemical handling.
- Must have a good command of operating within a QMS.
- Exemplary attention to detail, methodical approach and accustomed to working in a busy and demanding environment.
- Strong communication and organisational skills; able to collaborate well within a multidisciplinary environment.
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