at APN Software Services Inc. in Newark, Delaware, United States
Job Description for 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 such as, DM Vista, SCS Stratus, Centaur and Atellica analyzers.
• Completes analytical related testing/processes on analytical instruments such as Titrator, Karl Fisher, UV-VIS, Spectrophotometer and pH meter.
• Performs the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using analytical instruments and diagnostic analyzers.
• Compiles, analyzes, and interprets 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 test processes.
• Interacts with others inside/outside work group: 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.
• 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.
• Familiar with GMP, GLP, and GDP processes
• Mathematical skills: concentration calculations and statistical analysis.
• Computer skills: customary MS Office programs, SAP, LIMS, and/or Clinical testing software.
• Laboratory skills: operation, maintenance and troubleshooting of analytical instruments and chemistry assays.
• Demonstrates 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.
• 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.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.