Mishawaka, United States
about 1 year ago
The lab technician will work as a member of the QCE laboratory group. The purpose of this position to help support QCE product release laboratory functions. The lab technician will be required to perform activities in the quality control laboratory supporting Manufacturing needs to ensure timely delivery of quality products to our customers.
This position is a Quality Control function in which the lab technician will work with a team of lab technicians to help ensure timely release of intermediate and finished good products. This facility manufactures and releases products related to Diabetes and Urinalysis medical device product lines. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required.
Major Job Responsibilities
- Performs a wide variety of assignments according to established procedures, including but not limited routine tests, data review and analysis, and solution preparations
- Provides inputs used for the purpose of control charting and trending of data collected through the release process
- Communicates issues encountered in the lab to initiate the investigation phase to the lab supervisor
- Ensures lab inventory tracking is up to date
Required Knowledge/Skills and Experience
- Ability to discern colors based on visual color product testing requirements
- Well-developed written and verbal communication skills
- Solid interpersonal and collaboration skills
- Ability to work in a fast paced environment, working well independently or in a team environment
- Proficient in Windows-based applications including Microsoft Access and Minitab Statistical Software
- Typically 1-2 years of successful experience in quality processes and knowledge of quality related processes and systems
- Knowledgeable of 21 CFR Part 820 regulations and ISO 13485 standard requirements
BS in chemistry or biology or equivalent combination of education and experience.