DiaSorin Looking for Laboratory Lead at Stillwater, MN  Full Time

This position is responsible for overseeing material processing, reagent formulation, technical manufacturing, in-process and final quality control of reagents, components and in-vitro diagnostic products in the laboratory environment.

• Lead team members in the laboratory environment.
  • Help guide employees through builds and quality control activities.
  • Provide input into performance reviews, includes competency assessment.
  • Schedule laboratory training of new employees and assist in training.
  • Occasionally provide team training sessions.

• Planning / Execution of Work
  • Work with area supervisor to manage reagent build and QC schedules. Assign work to distribute group workload evenly and appropriately according to skill and experience level.
  • Demonstrate GMP and GLP in the laboratory environment. Ensure compliance with all regulatory requirements. Ensure the maintenance of proper documents by correcting and documentation of errors.
  • Support team goals for Backorder, Obsolescence, Scrap and other annual goals.
  • Maintain clean work space in QC and Reagent Prep Labs. Schedule group Reagent Prep and QC duties, including lab and equipment maintenance as needed.
  • Perform material processing and reagent formulation for bulk intermediates and components.
  • Perform in-process and final quality control for LIAISON products. Perform validation testing as needed.
  • Analyze testing results of technical manufacturing, quality control or product performance to determine acceptability of product relative to established requirements.
  • Participate in inventory accountability – PSA count, cycle counts, accurate kitting, etc.
  • Participate in team meetings and attend all group training sessions.
  • Maintain assay spreadsheets, QC panel inventory, QC strategy and assay facesheets.

• Quality
  • Execute investigations for root cause determination and troubleshooting activities with assistance from supervisor and product support team.
  • Write NCR/Deviations and use risk assessment at intermediate level.
  • Write/Complete Validation plans, reports, and activities.

• Safety
  • Perform work in a safe manner consistent with DiaSorin’s health, safety and environmental policies and assume responsibility for personal safety and that of co-workers to result in a safe work environment for all employees and the protection of the environment and the community at large.
  • Ensure that team members follow all Safety policies to ensure a safe work environment.

• 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

• 3+ years of related laboratory experience or demonstrated competence within the in-vitro diagnostic industry

• Knowledge of good laboratory and good manufacturing practices (cGMP)

• Knowledge and practice of statistical analysis and reporting methods

• Understanding of immunology and immunoassay technology and systems

• Functional knowledge of laboratory and manufacturing equipment and processes

• Understanding of Quality Control and manufacturing techniques

• Experience with MS Office, advanced experience with Microsoft Excel

• Familiarity with Google Suite

• Decision-making ability and leadership skills

• Demonstrated ability to train team members

• Ability to present information in a clear and concise manner

• Ability to lead a team of Process Scientists

• Proven ability to work with minimal supervision

• Ability to determine product disposition, perform and lead validations, write Quality Exceptions (Deviations and Non-Conforming Reports), perform internal control assignments

• Ability to organize schedule in order to ensure timely delivery of product

• Ability to work with other departments as well as across sites

• Demonstrated competency running LIAISON Instrument

• Intermediate SAP skills including the use of reporting functions and ability to train new employees, accordingly