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This position is responsible for Product Transfer activities including creation of formulation documentation, implementation of quality control procedures, validation reagent formulation including quality control and support of products post launch within the LIAISON Reagents department.
Job Responsibility:
Work in conjunction with Product Development in creation of all documentation for LIAISON® Reagent Manufacturing and Quality Control for new products. Create part numbers for new products in the design cycle
Create routings for new part numbers created in design cycle
Aid in creation of part numbers and routings for newer team members
Manufacture new Internal Controls for product in the design cycle
Serve on Core Teams for assigned development projects
Perform material processing and reagent formulation for bulk intermediates and components
Determine reprocessing need for calibrator, controls and conjugates, with assistance
Maintain clean work space in QC and Reagent Prep labs, consistent with Good Laboratory Practices (GMP)
Contribute to group Reagent Prep and QC duties, including lab and equipment maintenance
Utilize basic SAP (kitting, ordering to Cost Center, assign expiration dates, etc.) to ensure correct dating, accounting and flow through facility
Participate in inventory accountability - PSA count, cycle counts, accurate kitting, etc.
Perform in-process testing and final QC for LIAISON® products per established procedures using the LIAISON® analyzer family
Analyze testing results of technical manufacturing, quality control or product performance to determine acceptability of product relative to established requirements
Assign calibrator values to optimize kit performance, with assistance
Assign Kit Control ranges per established procedures
Perform second-checking to ensure accurate records
Ensure proper documentation by correcting errors noted in procedures and forms
Ensure proper documentation by creating new documents and making significant revisions to current documentation for process changes, clarity or consistency
Perform tasks assigned in NCR / Deviations and Validations
Perform tasks assigned in CAPA
Ensure safety of self and others by complying with all company safety policies, including use of PPE
Participate in team meetings and attend group training sessions
Monitor training required in SmartTrain and ensure timely completion of all company training requirements
Help with basic new employee training such as instrument use, basic software training, etc.
Contribute to business continuity or continuous improvement projects by suggesting improvements and completing assigned tasks
Complete assigned tasks related to investigations for root cause determination and troubleshoot product or process issues
Requirements:
Bachelor’s or Master's degree in Chemistry, Biology, Medical Technology OR related science field or a 2 year degree (i.e. MLT) with equivalent experience
5+ Years of related laboratory experience or demonstrated competence within the in-vitro diagnostic industry
Comprehensive understanding of immunology and immunoassay technology and systems
Ability to work in a regulated industry
Working knowledge of general lab equipment (e.g. pH meter, balances, mixers, etc.)
Knowledge of good manufacturing practices (GMP)
Knowledge of statistical analysis and reporting methods
Ability to train and mentor team members on basic group procedures and tasks
Ability to train and mentor team members in higher level skills
Proven ability to work with minimal supervision
Working knowledge of MS Excel
Familiarity with Google Suite
What we offer:
comprehensive plan of health benefits
retirement and financial wellbeing
time off programs
wellbeing support and perks
may be eligible to participate in an annual incentive program
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