Process Scientist II

diasorinsp•Stillwater, MN

9d•$70,000 - $85,400•Onsite

About The Position

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.

Requirements

Bachelor's Degree or Master's degree in Chemistry, Biology, Medical Technology or related science field or a 2 year degree (i.e. MLT) with equivalent experience Required
3+ Years of related laboratory experience and/or demonstrated competence within the in-vitro diagnostic industry Required
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, familiar with Google Suite
Ability to work with minimal supervision
Knowledge of statistical analysis and reporting methods
Ability to train team members on basic group procedures and tasks
Advanced skills in mathematical and calculations, writing and documentation skills, analytical skills, and ability to grasp complex concepts and solutions.
Correctable Vision (inspection work) and Ability to Distinguish Color (Label Inspection) required.

Responsibilities

Perform material processing and reagent formulation for bulk intermediates and components.
Determine reprocessing needs for calibrator, controls, and conjugates.
Perform Good laboratory practices - maintain clean work space 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. Additionally, create and run reports and train others on the use of SAP.
Participate in inventory accountability - PSA count, cycle counts, accurate kiting, etc.
Perform in-process testing and final Quality Control 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.
Assign kit control ranges per established procedures.
Monitor internal control supplies and manufacture new controls as needed.
Assign internal controls using bias methods to ensure consistent kit performance.
Perform second-checking to ensure accurate records.
Perform trending of internal controls and other critical to quality specifications for assigned products to ensure proper performance of kit and controls.
Follow regulatory requirements - follow document instructions and maintain reasonable documentation error rates.
Ensure proper documentation by: Correcting errors noted in procedures and forms, Ensuring 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.
Write NCR / Deviations.
Write and execute Validation Plans and Reports.
Perform Risk Assessments.
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..
Help with intermediate level employee training such as more complex QC processes and assignment of controls, calibrators, etc.
Contribute to business continuity or continuous improvement projects by: Suggesting improvements and completing assigned tasks. Executing investigations where needed, defining project/scope and writing quality plans and/or validation plans.
Complete assigned tasks related to investigations for root cause determination and troubleshoot product or process issues.
Execute investigations for root cause determination and troubleshoot product or process issues.