Position: Associate

Job type: Full-time

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Job content

Exciting Reagent Production Technician Opportunity:

The Client:

Charlton Morris is proud to be working with a healthcare technology and diagnostics company focused on expanding access to care. They have created the world’s first FDA-cleared, CLIA-Waived, point-of-care platform for chlamydia and gonorrhoea testing in both males and females. Their rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. Our client provides a technology platform that provides the necessary tools to connect communities with convenient diagnostic testing programs through self-collected samples, high-quality laboratory partnerships, and a full continuum of clinical care where and when it’s convenient for them. Their solutions can broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere. They work with universities, hospitals, clinics, public health departments, k-12 schools, employers and other organizations to provide patient-centric solutions for their communities.

Values:

Our client is fully aware of the importance of a diverse and workforce and considers this to be one of its core values.

The Position:

  • Follow manufacturing standard operating procedures (SOPs) for the production of formulated reagents at a cGMP/ISO13485 compliant production site
  • Follow QC procedures for the testing of incoming raw materials, goods in, formulated reagents and final product
  • Operate according to cGMP and ISO13485
  • Produce and maintain accurate production records (MBRs and forms) for manufacturing, QC and IQ/OQ/PQ activities
  • Implement site management activities (equipment maintenance and calibration, cleaning, health and safety, waste management, etc) as instructed by the production manager
  • Maintain training records up to date

Education, Experience and Demonstrated Skills:

  • BSc in a relevant scientific discipline
  • Experience (2y+) in cGMP manufacturing of formulated reagents (pharma/ medical devices industry)
  • Commercial in vitro diagnostic / medical devices product manufacturing experience
  • Experienced in ISO13485 / cGMP compliance
  • Process Verification & Validation experience
  • QC and validation for raw materials, reagents and finished product
  • Ability to strictly adhere to production procedures
  • Completion and maintenance of production records to procedures
  • Background in formulations manufacturing
  • Equipment and process validation
  • Experience working with eQMS systems
  • Attention to detail & well organised
  • Team working skills
  • Competent in the use of Microsoft Office (Word Excel, PowerPoint, Teams)

If this sounds like your next opportunity, please apply below.

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Deadline: 25-06-2024

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