Job Overview
We are seeking a skilled Lab Technician to join our team. As a key member of our quality team, you will play a crucial role in shaping the development of groundbreaking technologies and ensuring each stage of our innovation process meets the highest standards of integrity and safety.
Your Key Responsibilities:
* Perform routine testing services using established procedures/protocols (e.g., sterility, bioburden, aseptic filtration, environmental collection and testing, receive, inspect, in-process solutions, etc).
* Collect environmental lab samples from multiple cleanrooms.
* Perform data entry of routine testing.
* Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
* Assist in testing validation/revalidation activities for critical systems and equipment under close supervision.
* May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule.
* Update operating procedures and ensure that specifications are in compliance with GMP, Environment, and Safety regulations.
* Other incidental duties.
Required Skills and Qualifications
To be successful in this role, you will need:
* Bachelor's Degree or equivalent in a related science field.
* 1 year of previous experience working in a laboratory environment.
* Good written and verbal communication, interpersonal, and relationship-building skills.
* Able to read, comprehend, write, and speak English.
* Good computer skills, including usage of MS Office.
* Moderate knowledge of laboratory processes.
* Knowledge of QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations.
* Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
* Must be able to work in a team environment.
* Ability to provide feedback in a professional, direct, and tactful manner.
* Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
Preferred Qualifications
The following qualifications would be beneficial for this role:
* Good written and verbal communication, interpersonal, and relationship-building skills.
* Ability to read, comprehend, write, and speak English.
* Good computer skills, including usage of MS Office.
* Strict attention to detail.