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This position is responsible for material processing, reagent formulation, technical manufacturing, in-process and final quality control of reagents, components and in-vitro diagnostic products.
Job Responsibility:
Perform material processing and reagent for formulation bulk intermediates and components
Determine reprocessing need for calibrator, controls, and conjugates with assistance
Perform Good laboratory practices - maintain clean workspace in QC and Reagent Prep labs. Contribute to group Reagent Prep and QC duties, including lab and equipment maintenance
Utilize 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 Quality Control for LIAISON products per established procedures using the LIAISON analyzer family
Assign calibrator values to optimize kit performance
Assign kit control ranges per established procedures
Monitor internal control supplies and manufacture new controls as needed
Perform second-checking to ensure accurate records
Ensure proper documentation by correcting errors noted in procedures and forms (ECO) with assistance
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:
Associates degree in Chemistry, Biology or Medical Technology required
Bachelor's or Master's degree preferred in Chemistry, Biology, Medical Technology or related science field or a 2 year degree (i.e. MLT) with equivalent experience
1+ years of related laboratory experience and/or demonstrated competence within the in-vitro diagnostic industry
Basic understanding of immunology and immunoassay techniques
Ability to work in a regulated environment
Working knowledge of general lab equipment (e.g. pH meter, balances, mixers, etc.)
Working knowledge of MS Excel
familiarity with Google Suite
Basic understanding of statistical analysis
Advanced skills in: Math and calculations
Writing and documentation
Grasping complex concepts and solutions
Problem-solving and analytical skills
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