Lab Formulations Technician

T1 Formulations Technician

Job Description

The T1 Formulations Technician prepares calibration vials used in diagnostic medical equipment for hospitals and clinics, ensuring all materials meet strict quality and regulatory standards. This role combines hands‑on laboratory work with analytical testing and data review in a regulated manufacturing environment, supporting products that simplify, automate, and innovate complex biomedical testing.

• Prepare vials of calibration material used in diagnostic medical equipment, following established procedures and specifications.

• Apply analytical skills and scientific methods to perform daily laboratory tasks, including pipetting and running DXI
  800 and DXI
  19000 instruments.

• Set up, calibrate, test, and troubleshoot reagent components and instruments to ensure accurate performance.

• Conduct testing on solutions, including pH, conductivity, and density measurements, to verify adherence to production and process specifications.

• Follow and document work according to FDA Quality System Regulations (QSR) and Good Manufacturing Practices (GMP).

• Adhere to all applicable regulatory requirements and standard operating procedures (SOPs) throughout the formulation and reagent preparation processes.

• Perform laboratory work to make buffers and prepare materials in accordance with detailed SOPs for calibrator production.

• Run functional and analytical tests on prepared materials and reagents, and review data to ensure all specifications are met.

• Complete non-conformance investigations and corrective and preventive actions (CAPAs) as required.

• Assist with scheduling, inventory activities, and other production‑related tasks to support continuous operations.

• Work independently in the laboratory, managing daily workload and seeking out information or solutions when questions arise.

• Maintain accurate records and documentation for all laboratory activities, tests, and results in compliance with internal and external requirements.

• Associate or Bachelor's degree in a science‑related field.

• At least 3 months of laboratory experience, which may include academic lab work.

• Demonstrated ability to follow and articulate experience with standard operating procedures (SOPs).

• Ability to work independently, supported by positive reference feedback.

• Strong initiative and willingness to seek out answers and solutions when faced with new or challenging tasks.

• Comfort working in a regulated manufacturing and production environment.

• Ability to perform basic analytical testing such as pH, conductivity, and density measurements.

• Capability to use laboratory instruments, including automated analyzers such as DXI
  800 and DXI
  19000, after training.

• Pipetting experience in a laboratory setting.

• Experience working under Good Manufacturing Practices (GMP).

• Familiarity with FDA Quality System Regulations (QSR) or similar regulatory frameworks.

• Experience with non-conformance investigations and corrective and preventive actions (CAPAs).

• Exposure to chemistry‑based laboratory environments and buffer preparation.

• Experience with data analysis and computer‑based review of test results.

This role is based in a regulated manufacturing and production environment focused on the development, manufacture, and marketing of products that support complex biomedical testing. One position is available on second shift, working Monday through Friday from 2:00 p.m. to 10:30 p.m. The work is primarily laboratory-based, with approximately 70% of time spent making buffers and preparing materials and about 30% devoted to non‑conformances, CAPAs, scheduling, and inventory tasks.

The main laboratory is large and chemistry-focused, with work centered on following SOPs for calibrator production, pipetting, performing functional and analytical testing, and conducting computer-based data analysis to confirm that specifications are met. The role involves direct labor laboratory work that is highly independent. The campus is located on Lake Hazeltine and features walking trails between buildings, convenient access to central Chaska shops and restaurants, and is approximately a…