Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements. We are involved in every facet of the industry, including research, development, manufacturing and marketing and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry-level candidates that are interested in working for a great company with opportunities to grow, competitive pay and benefits.
Summary
- Develop and validate/verify HPLC, UPLC_MS/MS, ICP_MS, GC_MSMS methods for raw, in-process and finished products.
- Perform routine and non-routine physical and chemical testing of raw, in-process and finished products using various analytical methodology (chromatography, spectroscopy, physical and chemical separation techniques). Process, interpret, trend and report testing results in a timely and professional manner. Assist with development, validation, and periodic review of lab testing methodologies. Lead investigations of Out-of-Trend (OOT) and Out-of-Specs (OOS) results. Comply with all applicable regulations and policies.
Essential Duties & Responsibilities
- Develop and validate/verify HPLC, UPLC_MS/MS, ICP_MS, GC_MSMS methods for raw, in-process and finished products.
- Performs routine and 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).
- Perform testing with accuracy and precision; maintain accurate and detailed records.
- Prepare sample, standard and reagent solutions as required by the test methods
- Handle and store all chemicals according to safely guidelines. Ensure that chemicals are within their respective shelf life.
- Operate and maintain laboratory equipment (pipettes, pH meters, analytical balances…) and instruments (IR, HTLC, UV, HPLC, UPLC_MSMS, ICP_MS, GC_MSMS).
- 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.
- Monitor and evaluate stability studies data to establish stability trends.
- Evaluate the suitability of the reference standards used in the quantitative assays.
- Troubleshoot instrument errors as needed. Ensure that adequate documentation is kept in the appropriate equipment logbook. Promptly report incident to senior chemist and/or supervisor.
- Communicate testing status in a timely and effective manner to management and to the lab coordinators.
- Recommend opportunities for continuous lab improvement including new or revised analytical technologies.
- Assist with training junior staff in the usage and maintenance of analytical instruments (HPLC, ICP_MS, GC_MSMS, UPLC_MSMS) and on testing methodologies.
- Revise SOPs for compliance with cGMP and cGLP and creates original SOPs
- Comply with cGMP, cGLP and other applicable government regulations; as well as company compliance guidelines, standards and objectives.
- Coordinate lab activities and give final approval for QC sample release in the absence of the Lab Manager and /or Chemistry Supervisor.
- Perform other duties and special projects as assigned and directed by management.
Qualifications
- BS or MS degree in Chemistry, Biochemistry, Chemical Engineering or related science degree.
- Minimum 5 years 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 highly desirable (such as ICP/MS, HPLC/MS, GC/MS/MS or UPLC/MS/MS).
- Botanicals identity and potency testing knowledge desired
- 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.
- Exemplify accountability, high attention to detail, and organizational skills
- 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.
Physical Demands
- 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
Work Environment
- Computer workstation and climate-controlled office environment. QC Lab with various analytical instruments and various lab equipment, chemicals and solvents where PPE is required (lab coats, gloves, protective 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.
NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.