Natural Alternatives International

R&D Senior Technical Services Scientist

Carlsbad, CA, US

Onsite
Full-time
2 days ago
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Summary

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. Benefits * Free medical (one plan) and other medical plan options * Dental, vision, life insurance and other voluntary benefit options. * $1,000 Employee Referral Bonus * 3 weeks' vacation and 11 paid holidays * 401K including company matching and profit sharing * Opportunities for advancement * Comprehensive training * Tuition Reimbursement and more! Summary * Create, track, review, and maintain R&D technical documents related to formulations, raw materials, stability protocols and other department projects. Part of NAI Technical Services Team - subject matter experts within R&D for supplier management software system related to raw material information and documentation. Communicate directly with internal and external partners related to formula, raw material and other technical document and project-related tasks. Responsible for ongoing maintenance of R&D document files and preparation, review and routing of regulatory-related and technical documentation in support of product development process. Provide technical expertise and support to NAI cross-functional team, to ensure NAI provides accurate and timely information to customers regarding raw materials, formulas, third-party certifications and stability programs. Essential Duties & Responsibilities * Provide technical expertise and support within the R&D Technical Services and cross-functional team. * Prepare/assist with, review, update, track and maintain accurate records of all technical documents and relevant development projects (in collaboration with R&D formulation team and/or NAI cross-functional team members and/or external parties), including, but not limited to: * Formula Genesis reports * Raw material specifications * Pilot batch records * PO requisitions for raw materials * Material transfer requests for pilot and prototype materials * Raw material testing requests and reports * Product stability programs, reports, reviews and justifications * Maintenance of R&D stability chambers * Document change requests for raw materials * Raw material document, spec, sample and testing tracking sheets * Raw material and formula item keys * Certification documents for product formulas * aster batch records * Act as a secondary reviewer for technical documents created by the R&D Technical Services team * Review, track and maintain records of all technical documents and relevant development projects (in collaboration with R&D formulation and/or NAI cross-functional members), including, but not limited to: * Label copies * Product specifications * Master batch records * Act as Subject Matter Expert for NAI related to supplier management software system * Collaborate with internal and external partners to ensure documents/information are reviewed and updated accurately and efficiently in the system * Ensure documents/information are/is maintained accurately and efficiently in system * Collaborate with external/internal partners to facilitate configuration/updates of system as needed * Ensure formula/raw material related documentation is routed to and discussed with appropriate cross-functional team members in correspondence with NAI processes * Lead organization and maintenance of raw material and product certifications for NAI customers * Request, evaluate, update, maintain required certification documents for raw materials/formulas * Organize certification files for periodic audit by external certifying bodies * Liaise with external certifying body representatives and collaborate with NAI Quality team for review of NAI certification documentation and annual renewals of third-party certifications * Support, organize and track qualification of new, existing and replacement raw materials and alternate suppliers as assigned * Request, receive, review and evaluate, track, and maintain raw material documentation for NAI customer formulas and R&D projects * Liaise with raw material supplier representatives for raw material documents/information * Organize and track requests/receipt of raw material documents for R&D benchtops, pilots, production and NAI customer needs * Review raw material documentation for accuracy and NAI/customer requirements * Collaborate with R&D formulation team on raw material document updates or identified issues * Maintain raw material documentation files for updates * Responsible for sending, receiving, tracking, updating, maintaining compliance documents to/from raw material suppliers * Prepare/assist in preparation of regulatory and technical documents * Responsible for request, receipt, and tracking of raw material sample requests for R&D benchtop and pilot trials * Ensure R&D pilot lab has required materials and quantities for benchtop and pilot trials * Request, organize and track raw material samples and in-house materials for benchtop and pilot trials (collaborating with R&D Formulation Team) * Submit raw material samples for testing/evaluation and track status and results * Track out of spec raw material testing results and resolution * Collaborate with R&D formulation team and/or raw material supplier representatives on out of spec testing results to ensure prompt resolution * Label and track raw material samples for clinical trials * Build strategic relationships and maintain effective and professional communication with raw material suppliers in collaboration with NAI Purchasing team * Support Purchasing team in sourcing raw materials and obtaining necessary documentation to support evaluation of raw materials * Provide on-going internal and external technical support to ensure benchtop, pilot and production needs are met and customer requests are satisfied. * Assist in coordination of special projects as needed, such as but not limited to clinical studies, International Product Development and Registration documentation * Responsible for NAI conducted stability programs for NAI customers * Create and review/collaborate with R&D Technical Support team for customer stability protocols * Implement and track activities related to NAI stability protocols * Monitor product samples and submit for lab analysis * Gather, evaluate and summarize stability test results * Collaborate with R&D formulation team in review of stability data * Track stability program calendar, data, issues and resolution * Maintain and work with NAI personnel to schedule annual/required maintenance of R&D stability chambers * Collect, track and maintain customer stability data not conducted at NAI Other Duties * Maintain awareness of current developments within the functional discipline * Develop a network of raw material and technical support contacts within the industry * Collaborate with and support entire R&D department and cross-functional NAI teams * Take leading role for projects as assigned. * Perform other related duties as assigned Qualifications * Requires a four year college or university degree or its equivalent in Pharmacy, Chemistry, Food Science, Chemical Engineering, or related field * Requires a minimum of five years industry or similar industry R&D or Quality experience, ideally with an additional two years of related experience. Some knowledge of industry regulations - US or international a plus. * Possess knowledge and practical experience with nutraceutical, food or pharmaceutical ingredients and documentation, reviewing and summarizing analytical data, and a firm foundation in chemistry, mathematics, pharmaceutics and/or food science * Proficient in oral and written communication skills as well as effective organizational skills and the ability to make presentations and recommendations in the area of responsibility * Must be able to communicate effectively and professionally in a cross functional team environment and with external customers * Must have computer literacy, including word processing and spreadsheet software * Must have sound judgment and decision-making skills Supervisory Responsibilities * No direct supervisor responsibilities Physical Demands * Manufacturing and general office environment * Exposure to disagreeable elements is negligible * Frequent work in pilot plant and production facilities 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. Monday- Friday, 8:00 AM to 5:00 PM

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