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Quality Control / Quality Assurance Technician

CorTech LLC

This is a Full-time position in Newark, DE posted June 6, 2021.

Description
The individual will be responsible for Analytical Chemistry laboratory testing on instruments, troubleshooting and test process changes.
• Laboratory Testing will include and not limited to: perform 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 not limited to: Dimension, Atellica, Stratus CS, Cobas. Additional familiarity a plus: Advia, Centaur, Immulite.
• Instrument information system will include and not limited to: hard/software relative to LIMS and troubleshooting of laboratory systems.
• Process changes will include and not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software and process validations.

Time frame:
The position is planned for a 12-month period. Business needs may require additional periods.

Functions and responsibilities include:
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.
• Background in production processes relative to chemical and physical chemistry, concentration calculations and statistics.
• Leads the most complex quantitative and qualitative analysis, such as sampling, testing, and measuring using complex equipment.

Operations Quality Processes
• 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.
• Knowledge of FDA regulated environment and ISO/IVDD standards.
• Familiar with GMP, GLP and GDP processes.
• Knowledge or familiarity with SAP production system.
• Knowledge of Lean Manufacturing, Continuous Improvement, Six Sigma, and the various tools.

Personal Processes:
• Strong communication and interpersonal skills.
• Must be able to work independently, on a team and be able to multi-task and prioritize daily work.
• 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.

Desirable experiences: analytical chemistry, equipment maintenance, LIMS, test methods and /or process validations, medical technology.

Education:
– Ideal candidate will have a B.S. or equivalent degree with 1-3 year’s experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.

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