JOB DESCRIPTIOn - Quality Engineering Co-op

Overview

We are looking for smart, curious, and passionate individuals to join our culturally diverse team and contribute to our shared success.

As a Quality Engineer Co-Op, you will be responsible for executing QA and Compliance tasks and support investigations for Out of Specification, perform audits, support validations, trainings, QC lab functions and work cross functionally to support manufacturing.

Key Roles & Responsibilities

• Work closely with management to author, prepare and update SOPs and Work Instructions, as needed.
• Support activities to roll out and update training requirements when documents are updated and/or generated
• Identify and review non-conformances, determine root cause, and develop CAPAs in collaboration with Quality, Operations staff, and suppliers to address product quality issues and GMP/GDP monitoring
• Escalate critical issues to Quality/Operations leadership as required
• Perform training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis
• Partner with Engineering teams to complete validation activities as needed
• Perform other tasks as assigned that ensure compliance and regulatory requirements are maintained

Qualifications

• Pursuing a BS degree in Engineering, Biology or science
• Skill with database and spreadsheet software is essential
• Good written & verbal communication skills a must

Our Story

Biomeme was conceived and created to make the world a better place through the democratization of healthcare diagnostics. To that end, we have created technology that empowers anyone, anywhere (including low-resource settings with minimal space, electricity, and equipment) with the capabilities of a molecular lab in the palm of their hands. Over the last nine years, Biomeme has grown a vertically integrated organization spanning specimen collection, sample prep, assay, and instrumentation R&D, PCR reagent lyophilization, hardware, and consumable manufacturing, as well as molecular diagnostic testing services. With the low cost, ease-of-use, and unparalleled field portability of the Biomeme platform, we are uniquely poised to rapidly advance initiatives in emerging infectious diseases like COVID-19, as well as emergency preparedness, response, and recovery.