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- Vista, CA 92081
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Natural Alternatives International, Inc • Vista, CA
Posted 1 month ago
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Perform non routine physical and chemical testing of raw, in-process and finished products. Develop, validate and periodically review lab testing methodologies. Lead the investigation into Out-of-Trend (OOT) and Out-of-Specs (OOS) results. Assist with developing and maintaining adequate specifications for NAI raw materials and finished products. Provide technical expertise to the lab and other NAI departments.
Essential Duties & Responsibilities
· Performs non routine analytical testing of raw materials, in-process and final products in support of production and R&D.
· Conduct analytical (HPLC_UV, UPLC_MS/MS, ICP_MS, GC_MSMS) analysis per established lab SOPs and /or per external methods (vendor or customer methods, monographs, contract lab methods).
· Manage complex OOS investigations and review routine OOS reports from chemists. Make recommendations with respect to root cause and corrective action to prevent recurrence (i.e. CAPA), inclusive of changes to methods and procedures. Demonstrate an understanding of the factors impacting analytical test results.
· Compile, analyze, trend and interpret results of tests; determine acceptability and identify areas of improvement with rejection and deviation of data.
· Review peer data and reports and resolve complex testing issues using internal and external resources.
· Evaluate and compare contract labs, suppliers, and customers testing data to resolve testing discrepancies.
Method Development and validation
· Performs qualification and validation of lab equipment according to established SOPs.
· Manage the development, validation, and revision of lab testing procedures.
· Develop standards and assays, identify method limits of detection and quantitation.
· Statistically analyze raw data and propose modifications to test procedures, when applicable.
· Review pharmacopeia monographs, vendor and contract lab test methods to evaluate the feasibility of implementing those analysis in house.
· Identify opportunities for continuous lab improvement including new analytical technologies.
· BS or MS in Chemistry or Biochemistry. Doctorate degree a plus.
· Over 10 years of hands-on experience in an analytical lab preferably in the dietary supplement or a related industry.
· HPLC / UPLC experience required along two or more other analytical instruments (such as GC, ICP, FTIR/FTNIR, HPTLC, UV/VIS).
· MS experience required (such as ICP/MS, HPLC/MS, GC/MS/MS or UPLC/MS/MS).
· Excellent computer skills with knowledge of Microsoft Word and Excel required. Knowledge of Access and PowerPoint a plus.
· In depth understanding of scientific principles associated with method development, method transfer and method validation and hands-on experience with conducting such tasks.
· Ability to think critically and creatively to identify and solve scientific problems using internal and external resources.
· Ability to achieve and maintain high analytical standards with meticulous attention to detail.
· Ability to work independently and manage multiple projects simultaneously in a fast-paced, deadline driven environment.
· Strong interpersonal skills and excellent oral and written communication skills. Ability to communicate effectively in a credible and confident manner in a cross functional team environment.
• Able to work with and around hazardous materials, chemicals, and equipment
• The employee is regularly required to communicate with others (talk and hear)
• The employee is frequently required to sit and use hands to finger, handle or feel objects, tools or controls
• The employee is regularly required to stand, walk, and reach with hands and arms
• The employee must occasionally lift and/or move up to 50 pounds
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus
Computer workstation and climate-controlled office environment. Analytical laboratory requiring use of PPE (lab coats, gloves, lab glasses, and any additional PPE as necessary). May occasionally enter production areas where personal protective equipment might be required to prevent or lessens exposure to airborne-borne powdered nutritional supplement substances.