Quality Control Laboratory Technician 3

Position Overview /Responsibilities

This is a six-months contract position. 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:

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 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 QSR s 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 candidate's prior job experience