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Laboratory Technician

3 months ago

Newark, United States Ampcus Full time
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 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)