Basic Research
  • 19-Nov-2018 to 18-Feb-2019 (PST)
  • Compliance
  • Salt Lake City, UT, USA
  • Full Time

REPORTING TO: MANAGER, REGULATORY AFFAIRS & COMPLIANCE

JOB SUMMARY: The Regulatory Affairs/ Quality Assurance Associate is responsible for: controlling and maintaining necessary regulatory and quality documentation for raw materials, finished products, and product substantiation.  Also responsible for certain product life cycle management (PLM) approvals, reviews and audits of processes and documents, reviewing and investigating customer feedback and complaints and general clerical work (as needed).

POSITION DUTIES:                          

  • Obtaining required raw material technical documentation to meet U.S. and international requirements
  • Requesting Certificates of Free Sale, document legalization, apostilles, etc.
  • Filing, Auditing, and Bates stamping of internal product substantiation
  • Reviewing Bill of Materials for approval in PLM
  • Processing of internal/external study requests
  • Contract requests and renewals
  • Review of User Generated Content on social media outlets
  • Prepare internal Batch Production Records to be used during production
  • Coordinate with 3rd party laboratories to ensure proper tests are conducted
  • Review and audit internal processes, procedures and documentations
  • Assists design of Quality innovation and improvement
  • Quality trending analytics to drive continual improvement
  • Review and investigate customer feedback and complaints
  • General clerical assignments and other duties may be given as business needs evolve

POSITION QUALIFICATIONS: 

  • Bachelor's of Science (Biology, Chemistry, Health preferred) or related field
  • 1 year of industry related experience preferred strong preference for experience working with a nutraceutical and cosmetic companies
  • Strong analytical skills
  • Ability to follow established guidelines and work within specified procedures with a high degree of accuracy and detail orientation
  • Basic understanding of government regulations and processes
  • Action-oriented style of work and an ability to consistently exceed agreed upon expectations
  • Excellent interpersonal skills and an ability communicate business to business
  • Strong communication skills (written and verbal)
  • Strong problem-solving and critical thinking skills
Basic Research
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