at APN Software Services Inc. in Newark, Delaware, United States
Position Overview /Responsibilities
The technician will be responsible for activities related to manufacturing testing within the Quality Control Organization. Functions and responsibilities may include but are not limited to:
• Completes manufacturing related testing/processes on Diagnostic equipment/analyzers and analytical instruments such as, Dimension, Immulite, Olympus, Viva and/or pH meter.
• Performs the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using analytical instruments and diagnostic analyzers.
• Performs complex analysis of data in excel or LIMS which may include graphs and charts.
• Supports new product development, production support and/or reference materials testing.
• Performs routine instrument maintenance and maintains instrument logs.
• Follows testing schedule and protocols.
• Performs troubleshooting on testing processes, including testing equipment and data analysis.
• Interacts with other cross functional team members across the organization, such as Biochemists, Engineers, and Production Operations.
• Knowledge and experience in handling bio-hazard materials.
• Must be able to obtain DEA Clearance to work with controlled substances
• Potential to work on independent projects which may include defining tasks, setting priorities and driving project to completion.
• Flexible to work off shift schedule, overtime and/or irregular work hours as dictated by production schedule.
Knowledge/Skills and Experience
Knowledge and skills of a technical or specialty area, with 2-4 years of experience including but not limited to the following:
• Familiarity with GMP, GLP, and GDP.
• Demonstrate good mathematical skills: concentration calculations and statistical analysis.
• Computer skills: customary MS Office programs, SAP, LIMS and Clinical testing software.
• Laboratory skills: operation, maintenance and troubleshooting of analytical instruments and chemistry assays.
• Knowledge of QSR’s and ISO standards.
• Knowledge of FDA regulations.
• Knowledge of root cause investigations.
• Demonstrates ability to work independently and on a team.
• Demonstrate the ability to multi-task and prioritize daily work.
• Strong communication and interpersonal skills required.
• Bachelor’s degree in chemistry, biology, biochemistry, or 2-year degree with experience in Medical Diagnostics.
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.