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Quality Control Technician

Company: Epredia
Location: Kalamazoo
Posted on: February 13, 2020

Job Description:

At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast-growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career. Epredia was established in July 2019 through an acquisition by PHC Group from Thermo Fisher Scientific. Powered by trusted brands such as Richard - Allan Scientific, Microm, Shandon, Menzel Gl--ser and Erie Scientific, Epredia has a wide breadth of solutions that have and will continue to transform the anatomical pathology market. Today, we---re a global precision cancer diagnostics company working to improve patient outcomes by providing groundbreaking technologies. Since our humble beginnings in 1938, every product developed has been impacted by generations of employees who are committed to improving lives by enabling pathologists through enhancing precision cancer diagnostics. Position Summary This position is a bench analytical chemist role. The primary responsibilities include testing of raw materials, in-process and finished goods testing. Product approval and product release will be based off of the results of this testing. Key Responsibilities Follow site Standard Operating Procedures (SOPs) and Work Instructions (WI) Analyze chemical raw material samples. Analyze chemical bulk solution and finished goods samples for product release. Maintain laboratory instruments. Ability to work overtime and weekends to support manufacturing Responsible for contributing to the continual quality & reliability improvement of Epredia products and services. Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy. Responsible for performing tasks to support the quality system and quality policy as directed by QA management. Minimum Requirements/Qualifications Bachelor---s Degree in a science related field (i.e. chemistry or biology) Experience in an analytical chemistry laboratory preferred Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously Must be willing to work with and around hazardous chemicals. Must possess strong organizational skills. Experience of working with FDA regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable). Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable. Excellent interpersonal skills Excellent communication skills both written & oral Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel) Non-Negotiable Hiring Criteria Bachelor---s Degree in a science related field (i.e. chemistry or biology)

Keywords: Epredia, Kalamazoo , Quality Control Technician, Professions , Kalamazoo, Michigan

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