Quality Control Biochemist

Position: Quality Control Biochemist 1

Location: Glasgow Business Community Newark, DE - 19702

Duration: 12 Months

Description:

The individual will be responsible for 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, Dimension Vista, Atellica, Stratus CS, Cobas. Additional familiarity a plus: Advia, Centaur, Immulite.

• Process changes will include and not limited to: documentation, work instruction, qualification, validation, failure mode analysis, software and process validations.

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.

Education: Ideal candidate will have a B.S. or equivalent degree with 2-7 year’s experience in a relevant field with basic Chemistry/Biochemistry or Medical Technologist background.

Job Types: Contract, Full-time

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Newark, DE 19702: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Biochemistry: 3 years (Required)
• Laboratory experience: 3 years (Required)
• ISO/IVDD: 3 years (Required)

Work Location: One location