Quality Technician 3

Description:

Position Overview /Responsibilities
The technician will be responsible for activities related to manufacturing testing within the Quality Control Organization. Functions and responsibilities may include and are not limited to:

Key Attributes:
People skills interacting with others: inside/outside work group, process personnel across functions, scientists, engineers, and management.
Potential to work independently on projects which includes defining tasks, setting priorities, and planning materials.
Flexible to work overtime and/or irregular work hours as needed.
Complete all assigned tasks accurately and on time.

Planned Work:
Completes manufacturing related testing and processes for the Dimension RXL, EXL, and EXPAND, ADVIA and/or SYVA instruments. This may link to:
Product Verification testing
Product Assigned Value testing of calibrators.
In process and Semi-Finished testing of calibrators and reagents.

General:
Performs complex quantitative and qualitative analyses, including sampling, testing, and measuring using analytical instruments and diagnostic analyzers.
Compiles, analyzes, and interprets test data.
Perform/report analysis of data and calculations in excel or LIMS, with 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 test and manufacturing process systems.
May provide general guidance to others and train other QC employees.

Additional Areas:
May participate in new product development, production support, reference materials.

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.
Familiar with GMP, GLP, and GDP processes
Mathematical skills: concentration calculations and statistical analysis.
Computer skills: MS Office programs, SAP, LIMS, and/or ABC Clinical testing software.
Laboratory skills: operation, maintenance and troubleshooting of analytical instruments and chemistry assays.
Ability to work independently on a team and be able to multi-task and prioritize daily work.
Strong communication and interpersonal skills.
Knowledge of and experience in handling bio-hazard materials.

Education
Associate degree in a relevant field. Prior job experience highly valued.
Bachelor's degree in a relevant science (e.g. chemistry, biology, biochemistry, 2 year degree with experience in Medical Diagnostics or equivalent) or 5 year degree with experience (e.g. chemistry, biology, biochemistry, or equivalent).