One of our clients is looking for a talented and highly motivated Quality Engineer 1/ Biochemist 1. Please send your resume if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position.

Here are job position details for your review:

Job Title: Quality Control Biochemist 1
Pay Rate: $30 to 35/Hr
Duration: 12 Months
Job Requisition: JP00070222,JP00068275
Location: Newark, DE

This position is for the Healthcare Diagnostics division.

This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.

Description:

• The individual will be responsible for laboratory testing on instruments, troubleshooting and test process changes.
• Laboratory Testing will include and not be 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 not be limited to Dimension, Dimension Vista, Atellica, Stratus CS, 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.

Specialist aspects:

• The incumbent may be involved with multiple projects from a change and troubleshooting project perspective.
• Understanding the Quality Control processes
• learning the change process used at the site,
• Will work with a team on project plans, create or change documents, estimate timelines, and use various tools.

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.

Information Systems

• Experience with LIMS and information systems.
• Enters data into internal computer systems and generates documents as required.
• Strong computer skills in the knowledge of Microsoft Word and Excel, and macros.

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 the 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 2-7 years of experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.

Job Type: Contract

Salary: $30.00 - $35.00 per hour

Schedule:

• 8 hour shift

COVID-19 considerations:
Vaccination Required

Ability to commute/relocate:

• Newark, DE 19711: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Biochemistry: 1 year (Preferred)
• Laboratory experience: 1 year (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: One location

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