Reagent Production Technician (52873) - #147969

Description

Reagent Production Technician

Who We Are

binx health is a healthcare technology and diagnostics company focused on expanding access to care. The binx io is the world’s first FDA-cleared, CLIA-Waived, point-of-care platform for chlamydia and gonorrhoea testing in both males and females. Our rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. Our solutions have the ability to broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere. We work with universities, hospitals, clinics, public health departments, k-12 schools, employers and other organizations to provide patient-centric solutions for their communities. Our Values:

Our Values

We are…

B old – Tenac i ous – O n e Team – Fi x ated on Our Mission

At binx health, we know a diverse workforce adds to our collective value and strength as an organization. People of colour, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. binx health is proud to be an Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Responsibilities

The Position:

• Follow manufacturing procedures (SOPs) for the production of formulated reagents at a cGMP/ISO13485 compliant binx production site
• 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
• Follow and engage in the Quality Management System
• Perform an active role in identifying improvements to the manufacture processes, including the updates of Standard Operating Procedures and Job Aids
• Assisting with experimentation to define and characterise improvements for manufacture
• Maintain up-to-date training records
• Ad-hoc tasks may be assigned due to business needs.
  
  

Essential

Education, Experience and Demonstrated Skills :

• BSc in a relevant scientific discipline
• Ability to strictly adhere to production procedures
• Practical experience handling reagents
• High attention to detail
• Organised and logical approach to tasks
• Demonstrated ability to work as part of a team
• Competent in the use of Microsoft Office (Word Excel, PowerPoint, Teams)
• Proactive and efficient attitude
• Ability to adapt to new tasks
  
  

Desirable

• Experience (2y+) in cGMP manufacturing of formulated reagents (pharma/ medical devices industry)
• Commercial in vitro diagnostic / medical devices product manufacturing experience
• Equipment and process validation
• Completion and maintenance of production records to procedures
• Background in formulations manufacturing
• Knowledge of LEAN manufacturing
• Experienced in ISO13485 / cGMP compliance
• Experience working with eQMS systems