Quality Compliance Specialist. Position Summary. The Quality Compliance Specialist provides Quality Assurance support and helps administer the CAPA program and the internal and external audit programs. The Quality Compliance Specialist will assist with ensuring regulatory compliance for the company, including writing and revising relevant SOPs/WIDs and constructively implementing mechanisms for new regulations, standards, and/or regulatory guidan...
HSE Technician. Position Summary. The HSE Technician is responsible for promoting and assisting in the implementation of all HSE objectives including HSE programs, policies, and procedures with primary emphasis on occupational health and safety. The HSE technician’s principle responsibilities will include monitoring environmental practices and permitting to ensure compliance, assist with job safety analysis (JSA’s) and recommend corrective actio...
Position Summary. The Clinical Data Specialist assists the Clinical Team in the analysis of study data in support of BioFire Defense in vitro diagnostic (IVD) products. They provide input on study protocols, data collection, and data formatting. They also ensure that data is collected in adherence to study protocols, Good Clinical Practices (GCPs), Federal Regulations, company procedures, and other applicable regulatory requirements. They are als...
Manufacturing Technician. Position Summary. The Manufacturing Technician is responsible for manufacturing quality products efficiently, accurately, safely and on time. Their primary responsibility will be to operate. manufacturing equipment. to produce regulated and non-regulated products consistent with current Good Manufacturing Practices (cGMP), company policy and safety regulations. They will work on assignments that are routine in nature whe...
Position Summary. The Clinical Research Associate is responsible for the initiation and oversight of clinical evaluations in support of BioFire Defense in vitro diagnostic (IVD) products. They are the primary liaison between BioFire Defense and clinical study sites. They work closely with research personnel to ensure the integrity and safeguarding of clinical study data. They are also responsible for assisting Clinical Research Scientists in the ...
Laboratory Technician. Position Summary. The Laboratory Technician is responsible to weigh, measure, pipette, and check raw materials to ensure that manufacturing reagents contain the proper ingredients and meet quality standards. Their primary responsibility will be to formulate wet and freeze-dried reagents, buffer sub-assemblies, and finished goods. They will have a knowledge of commonly used concepts, practices, and procedures including PCR, ...
Position Summary. The Decontamination specialist is responsible for decontamination prevention efforts in all manufacturing work spaces. Cleans. in GMP and or clean room environments where PPEs or other gowning and entrance/exit procedures must be followed. Performs work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System. Principal Job Duties and Responsibilities. Perform all work in compliance with c...
