at VIVA USA Inc. in Newark, Delaware, United States
Quality Control Laboratory Technician 3:
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:
• Completes manufacturing related testing/processes on Diagnostic equipment and analyzers: DM Vista, Centaur and Atellica analyzers. This may link to:
• Method certification testing on various Diagnostic platforms.
• Stability testing and monitoring on DV and/or DM Calibrators.
• 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.
• Additional Areas:
• Completes manufacturing related testing/processes on analytical instruments such as Titrator, ICP, and Spectrophotometer and pH meter.
• 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 client 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.
• Strong learning skills will be a key foundation to career growth.
• 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. With mastery, may grow into trainer of others with less experience.
• Associate degree in a relevant field. Prior job experience highly valued.
• Bachelor 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).