Position Overview / Responsibilities
This is a six-month contract position. The technician will be responsible for activities related to manufacturing testing within the Quality Control Organization. Functions and responsibilities may include, but are not limited to:
- Completes analytical related testing/processes on analytical instruments such as Titrator, Karl Fisher, UV-VIS, Spectrophotometer, and pH meter.
- Completes manufacturing related testing/processes on Diagnostic equipment and analyzers such as DM Vista, SCS Stratus, Centaur, and Atellica analyzers.
- Performs the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using analytical instruments and diagnostic analyzers.
- Compiles, analyzes, and interprets large sets of test data.
- Performs complex analysis of data and calculations in Excel or LIMS, which includes graphs and charts.
- Enters data into internal software and generates documents as required.
- Performs periodic inspections of equipment and preventative maintenance work.
- Maintains instrument logs.
- Ability to follow protocol and schedules.
- Performs troubleshooting on issues that may arise during the testing process.
- Might be required to participate on cross-functional teams as needed (scientists, engineers, and management).
- Potential to work independently on projects which includes defining tasks, setting priorities, and driving to completion.
- Flexible to work overtime and/or irregular work hours as needed.
- Knowledge of QSRs and ISO standards.
- May require participation in new product development, production support, and/or reference materials.
- May provide general guidance to others and train lower-level employees.
Knowledge/Skills and Experience
Knowledge and skills of a technical or specialty area, with 3-5 years of experience including, but not limited to, the following:
- Understands the quality management system and ensures that their area complies with FDA, QSR, ISO, and IVDD standards.
- Familiarity with GMP, GLP, and GDP processes.
- Mathematical skills: concentration calculations and statistical analysis.
- Computer skills: customary MS Office programs, SAP, LIMS, and/or Siemens Clinical testing software.
- Laboratory skills: operation, maintenance, and troubleshooting of analytical instruments and chemistry assays.
- Knowledge and experience with analytical instruments and testing methodologies are a must.
- Demonstrates ability to work independently on a team and be able to multi-task and prioritize daily work.
- Strong communication and interpersonal skills.
- Knowledge and experience in handling bio-hazard materials.
Education
- Bachelor's degree in a relevant science (e.g., chemistry, biology, biochemistry, 2-year degree with experience in Medical Diagnostics or equivalent).
- Individuals with an associate degree may be considered, depending on the candidate's prior job experience.
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