What are the responsibilities and job description for the Quality Control Lab Specialist I position at USANA Health Sciences?
Description
USANA Health Sciences is seeking a well-rounded and adaptable individual to join our quality control laboratory as a QC Laboratory Specialist. In this position, you will work closely within the lab and with other USANA departments to problem solve and support our validation, verification, and transfer activities for raw materials and finish goods produced by USANA Health Sciences.
In this mid-level role, you will conduct analytical method validation, verification, and transfer activities for raw materials and finished goods produced by USANA Health Sciences. A successful candidate in this position will uphold USANA’s core values, plan for, anticipate, and adapt to changes in production schedules, and demonstrate problem-solving skills. Additionally, you will analyze data and ensure data integrity to support product quality in compliance with regulatory standards (FDA, ICH, USP, TGA).
Additional Essential Functions
USANA Health Sciences is seeking a well-rounded and adaptable individual to join our quality control laboratory as a QC Laboratory Specialist. In this position, you will work closely within the lab and with other USANA departments to problem solve and support our validation, verification, and transfer activities for raw materials and finish goods produced by USANA Health Sciences.
In this mid-level role, you will conduct analytical method validation, verification, and transfer activities for raw materials and finished goods produced by USANA Health Sciences. A successful candidate in this position will uphold USANA’s core values, plan for, anticipate, and adapt to changes in production schedules, and demonstrate problem-solving skills. Additionally, you will analyze data and ensure data integrity to support product quality in compliance with regulatory standards (FDA, ICH, USP, TGA).
Additional Essential Functions
- Validation Protocol: Perform laboratory testing—including accuracy, precision, specificity, linearity, ruggedness, and robustness studies—to establish method performance.
- Method Transfer & Verification: Manage the transfer of validated methods to QC laboratories and verify method performance at new sites.
- Data Analysis & Investigation: Analyze experimental data, interpret results, and conduct investigations for out-of-specification (OOS) or anomalous results.
- Instrumentation Handling: Ensure analytical instrumentation (e.g., HPLC, GC, UV, ICP-MS, LCMS, LCMS, LCMS, LCMSMS) is qualified and properly maintained.
- Bachelor’s degree in a science related field (Chemistry, Biology or Biochemistry)
- Experience in laboratory research and/or analysis
- Experience with Good Manufacturing Practices (cGMP).
- Strong analytical chemistry knowledge in one or more of the following instruments: LC, LCMS, LCMS/MS, GC, ICP-MS.
- Excellent documentation skills, ability to work independently in complex projects.
- Experienced in regulatory/pharmacopeia requirements for product testing and method validation
- Ability to perform basic scientific mathematical functions