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:
• Key Attributes:
• 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.
• Planned Work:
• Completes manufacturing related testing/processes on Diagnostic equipment and analyzers: SYVA, DM, 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 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.
• 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).
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.