Assembly and Distribution Technician

Biodesix•Louisville, CO

8d•Onsite

About The Position

The Assembly and Distribution Technician will work collaboratively with cross-functional teams to ensure the production of innovative diagnostic tests that meet FDA cGMP regulations and comply with the company's high standards of quality. The successful candidate will take ownership of initiating and completing quality documentation for kit builds, conduct product acceptance testing, maintain accurate inventory counts, and provide support for the efficient operation of the KanBan system for Manufacturing inventory. Additionally, the candidate will maintain a clean and organized work area, adhere to daily contamination controls, and respond quickly to environmental alerts. Finally, the candidate will be flexible and willing to take on other duties as assigned to support the success of the Manufacturing team.

Requirements

Strong organizational skills with exceptional attention to detail
Ability to read, write, understand, and clearly communicate in English
Proficiency in computer skills, including Excel, and e-mail systems
Ability to adapt to emerging situations and respond with a sense of urgency
Ability to consistently meet deadlines
Must adhere to all standard operation procedures within Quality Management System
Ability to train others on current processes

Nice To Haves

Shipping and International Shipping experience is a plus but not required
Medical Device Experience, preferred

Responsibilities

Be a key player in the production of our innovative diagnostic tests
Ensure that quality kits are expertly assembled and comply with FDA cGMP regulations
Actively monitor and accurately input information into our Kit Order and Distribution System
Collaborate with cross-functional teams to fulfill kit orders and support our dedicated clinicians in improving patient outcomes
Take ownership of initiating and completing applicable quality documentation for kit builds
Play an essential role in prepping finished goods for distribution and ensuring they meet our high standards of quality
Conduct Product Acceptance Testing on batches of finished goods to ensure they meet our rigorous standards
Help maintain accurate inventory counts and support the efficient operation of our KanBan system for Manufacturing inventory
Maintain a clean and organized work area and adhere to daily contamination controls to ensure the safety of our products
Act quickly to monitor, respond to, and correct environmental alerts in a timely fashion