Document Control Scientist

Natural Alternatives International Published: October 3, 2020
Location
Carlsbad, CA
Job Type
Full-time
Categories
Analyst / Research / Farm / Organics / Scientific /
(Number of Job Posting Views: 8)

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Description

~ Natural Alternatives International, Inc. (NAI) is the industry-leading formulator and manufacturer of customized nutritional supplements. We take a unique partnership approach to combine science-based formulation, advanced quality assurance testing methodologies, superior manufacturing and packaging capabilities as well as broad marketing experience to create quality nutritional products. ~

Position Overview

The Document Control Scientist is responsible for creation and/or acquisition, tracking and maintenance of R&D technical documents related to formulations, raw materials, and other department projects. This position communicates 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.

Essential Duties & Responsibilities

  • Assist with/Prepare, review, update, track and maintain records of all technical documents and relevant development projects (in collaboration with R&D formulation team and/or NAI cross-functional team members), including but not limited to:
    • Formula Genesis reports
    • Label copies
    • Raw material specifications
    • Product specifications
    • Product justifications
    • Master batch records
    • Testing requests
    • Testing results
    • Material transfer requests
    • Document change requests
    • Technical reports
  • Assist in ensuring formula/raw material related documentation is routed to appropriate cross-functional team members in correspondence with NAI processes
  • Organize and maintain raw material and product certifications for NAI customers
    • Request, evaluate, update and maintain required certification documents for raw materials and/or formulas
    • Organize certification files for periodic audit by external certifying bodies
    • Liaise with external certifying body representatives for review of NAI certification documentation
  • 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 documentation and/or information
    • Organize and track requests/receipt of raw material documents for R&D benchtops, pilot and production.
    • Review raw material documentation for accuracy and R&D requirements
    • Collaborate with R&D formulation team on raw material document updates or identified issues
    • Maintain raw material documentation files for updates
    • Assist in sending and receiving compliance documents from raw material suppliers
  • Assist in preparation of regulatory and technical documents
  • Request, receive, and track raw material sample requests for R&D benchtop and pilot trials
    • Ensure R&D pilot lab has required materials for benchtop and pilot trials
    • Collaborate with R&D formulation team to request, organize and track raw material samples and in-house materials for benchtop and pilot trials
    • Submit raw material samples for testing/evaluation and track status and results
    • Collaborate with R&D formulation team and/or raw material supplier representatives on out of spec testing results
    • 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
  • Lead NAI conducted stability protocols for NAI customers
    • Collaborate with R&D formulation team in creation of 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

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 two years industry R&D or Quality experience, ideally with two years of related experience. Some knowledge of industry regulations – US or international a plus.
  • Possess knowledge and practical experience with nutraceutical or food 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

Natural Alternatives International is committed to equal employment opportunity. We will not discriminate against employees or applicants for employment on any legally-recognized basis including, but not limited to: race, religion, sex, national origin, age, disability, veteran status, uniformed service member status, or any other category protected by applicable federal, state, or local law.

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