55! The number of reagents responsible for manufacturing to support assay development, validation, and clinical trial testing both in-house and globally with 10 new reagents in the pipeline.

This individual will work in a small group to produce and perform QC analysis on high quality in vitro diagnostic (IVD) reagents in support of QC release testing and patient testing at Navigate BioPharma.

* Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
* Perform activities necessary to deliver high quality reagents in support of QC release testing, reagent kits used for patient testing, and specimen collection kits in support of clinical trials, including the following:
* Raw material, in-process, stability, and/or final product inspections
* Manufacture of reagents, such as material handling and inventory management
* Adherence to and meticulous maintenance of cGMP practices
* Raw material procurement, disposition and inventory maintenance
* Contribute to the creation, maintenance, review and update of manufacturing processes, documents, and records to ensure completeness, accuracy, consistency and clarity as well as compliance to cGMP and QSR requirements
* Support the maintenance and continuous improvement of GMP/QSR quality systems
* Support regulatory filings and inspections of company, as related to reagent manufacturing practices
* Communicate and coordinate directly with internal customers to ensure reagent demands are met in a timely manner in support of sample testing and QC release activities
* Trains associates on operational procedures, as needed
Other responsibilities
* Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
* Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
* Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
* Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed

PHYSICAL DEMANDS
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

WORK ENVIRONMENT
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.
The work environment involves moderate exposure to unusual elements including; extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company's Safety and Injury, Illness and Prevention Plans.