Lab Technician

Lab Technician

The Lab Technician plays a key role in the production of chemical and biological reagent products by formulating, filling, testing, and packaging materials according to established procedures and regulatory requirements. This role involves setting up, calibrating, testing, and troubleshooting reagent components and instruments, as well as performing analytical testing on solutions to ensure they meet production and process specifications. The position is highly independent and combines hands-on laboratory work with computer-based data analysis in a chemistry-focused environment.

Responsibilities

• Formulate, fill, test, and package a variety of chemical and biological reagent products in accordance with standard operating procedures and production specifications.
• Follow SOPs and other written and verbal instructions throughout the manufacturing process while maintaining compliance with FDA requirements.
• Independently execute daily work related to reagent formulation, filling, testing, and packaging with minimal supervision.
• Apply analytical skills and scientific methods to perform routine laboratory tasks and ensure product quality.
• Set up, calibrate, test, and troubleshoot reagent components and instruments to support accurate and reliable production processes.
• Conduct testing on solutions, including pH, conductivity, and density measurements, to verify adherence to production and process specifications.
• Perform raw material testing using techniques such as HPLC and ICP to confirm quality and suitability for use in production.
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and applicable regulatory requirements throughout all manufacturing activities.
• Use pipetting and other standard laboratory techniques to prepare reagents and calibrators according to established protocols.
• Run functional testing on analytical tests and perform data analysis to ensure that product specifications and quality standards are consistently met.
• Maintain accurate records of testing, calibration, and production activities in accordance with laboratory and regulatory standards.

Essential Skills

• Bachelor's degree in a science-related field.
• At least 3 months of laboratory experience, which may include academic or school-based lab work.
• Demonstrated ability to follow and articulate previous experience with standard operating procedures (SOPs).
• Ability to perform basic analytical testing, including pH, conductivity, and density measurements.
• Experience or familiarity with setting up, calibrating, and troubleshooting laboratory instruments and equipment.
• Capability to apply scientific methods and analytical thinking to daily laboratory tasks.
• Understanding of FDA Quality System Regulations (QSR) and Good Manufacturing Practices (GMP), or willingness to learn and apply these standards.
• Comfort working independently and managing assigned tasks with minimal supervision.
• Basic computer skills for data entry, data analysis, and documentation of laboratory results.

Additional Skills & Qualifications

• Experience with raw material testing using HPLC and ICP or similar analytical instrumentation.
• Background in chemistry or a closely related scientific discipline.
• Strong attention to detail and accuracy in both laboratory work and documentation.
• Effective communication skills to clearly describe previous experience following SOPs and to collaborate with team members across shifts.
• Ability to balance hands-on laboratory work with computer-based data analysis and documentation.
• Interest in working within a regulated environment and maintaining high quality standards.

Work Environment

This is a first-shift, Monday–Friday position in a large, chemistry-based main laboratory focused on reagent and calibrator production. The start time is flexible between 5:00 a.m. and 7:45 a.m. for an eight-hour shift, with the expectation of being present before the 8:00 a.m. team activities. The work is primarily direct labor in the lab, involving pipetting, reagent preparation, functional testing on analytical tests, and adherence to SOPs, combined with computer-based work and data analysis to confirm that…