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Production Specialist
2 months ago
Job Opportunity: Production Scientist - IVD
About the Role:
This is a newly created position within a thriving biotechnology organization. As a Production Scientist, you will report to the Senior Production Scientist and contribute to key duties in the manufacture and quality control of specialized reagents.
Key Responsibilities:
- Preparation of reagents, lyophilization, and quality control of small to medium-scale batches.
- Receipt and handling of reagents and chemicals, including aliquoting, storage, and uploading onto the Quality Management System (QMS) as necessary.
- Collaboration with Contract Manufacturing Organizations (CMOs) and in-house specialists to support production scaling activities.
- Development and implementation of quality control and validation protocols, ensuring adherence to regulatory processes.
- Reporting of quality control pass and fail results, monitoring non-conformance, and taking corrective action.
- Adherence to ISO 13485 and FDA regulations.
- Maintenance of accurate records and documentation of production activities in accordance with company policy.
Requirements:
- Bachelor's degree or equivalent 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 setting with devices in development.
- Proficiency in real-time polymerase chain reaction (RT-PCR) and other molecular techniques, such as reagent and chemical handling.
- Strong understanding 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 organizational skills, with the ability to collaborate effectively in a multidisciplinary team.
About SRG:
SRG is a leading biotechnology organization dedicated to developing innovative solutions for the healthcare industry. Our team is passionate about delivering high-quality products and services that make a meaningful impact on people's lives.
