Position: Quality Engineer/ Biochemist
Location: Newark, DE 19702
Term: 12 months
Day-to-Day Responsibilities:
- Responsible for laboratory testing on instruments, troubleshooting, and test process changes.
- Laboratory Testing will include and is not limited to: Performing test methods on various chemistry, analytical and diagnostic equipment. Strong knowledge of GLP and GDP as per clinical chemistry practices.
- Instrument Systems maintenance and Testing will include and are not limited to: Dimension, Dimension Vista, Atellica, Stratus CS, and Cobas. Additional familiarity a plus: Advia, Centaur, Immulite.
- The instrument information system will include and is not limited to: hard/software relative to LIMS and troubleshooting of laboratory systems.
- Process changes will include and are not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software, and process validations.
- Analytical Testing: Understands Quality Control, Testing, Chemistry, and Biology as pertains to the diagnostics industry.
- Completes manufacturing-related testing and processes for Diagnostic equipment and analyzers.
- Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.
- Enters data into internal computer systems and generates documents as required.
- Learn and follow the Quality Change Process required in the Quality Control and Operations area.
- Develops, recommends, and implements technical documentation changes to meet regulatory quality requirements and SAP-based manufacturing system needs.
- Identifies problems as they occur and takes appropriate steps to solve them.
- Flexibility to work overtime and/or irregular work hours as needed.
- Formatting, writing, and editing of very complex technical documentation
- Plan, author, document, and execute projects.
Is this a good fit? (Requirements):
- Bachelor of Science or equivalent degree with 2-7 years experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.
- Experience with LIMS and information systems.
- Strong computer skills in the knowledge of Microsoft Word and Excel, and macros.
- Knowledge of FDA-regulated environment and ISO/IVDD standards.
- Familiar with GMP, GLP, and GDP processes.
- Knowledge or familiarity with the SAP production system.
- Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.
- Strong communication and interpersonal skills.
- Able to work independently, and on a team and be able to multi-task and prioritize daily work.
- Background in production processes relative to chemical and physical chemistry, concentration calculations, and statistics.