The position is responsible for leading quality assurance and regulatory compliance efforts in maintaining compliance programs for dietary supplements (21 CFR Part 111), nutritional supplements and foods (21 CFR Part 117). The position oversees a wide range of quality programs, food safety, third party product certifications, audits, regulatory inspections and visits, customer complaints, root cause analysis for non-conforming products, and corrective and preventive actions (CAPA).
The position reports to the Senior Quality Assurance Manager.
Job Expectations:
Execute Quality Department programs and activities ensuring compliance with food safety standards, regulatory compliance to domestic/international regulations, company policy and industry best practices including GMP, Standard Operating Procedures (SOPs) and Food Safety Plans.
Develop, evaluate and implement Standard Operating Procedures (SOPs).
Manage and maintain Quality Management Program and iTested Program for House Brands products.
Work in collaboration with vendors/suppliers, laboratories and third party certification bodies to ensure product certification requirements are maintained and implemented.
Communicate, collaborate cross-functionally to assist Quality Department and Managements to lead necessary status and activities related to product certifications and other quality system requirements.
Monitor and report quality-related problems identification and resolution in order to adhere to the project timelines.
Ensure Vendor Qualification programs are in place and continuously monitor their status and maintaining performance metrics.
Support contract manufacturers and supply chain to manage finished product compliance.
Serve as the primary liaisons and compliance authority for assigned program areas in the absence of Senior Quality Assurance Manager and Quality Control Manager.
Perform other duties as requested.
Knowledge, Skills and Abilities:
Required:
Strong analytical, data management knowledge
Ability to communicate written and verbally in a professional manner with people at all levels of the organization and external contacts
Experience with Microsoft Office Suite (Word, Excel, PowerPoint)
Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms) preferred
Experience Requirements:
3+ years of relevant industry experience in R&D, Manufacturing, Quality Assurance and/or Regulatory Affairs
Certified Auditor a plus
PCQI certified a plus
FDA regulations
Education Requirements:
Bachelor’s Degree in Chemistry, Microbiology, Food Science or related field preferred, or a combination of education and equivalent work experience).
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At iHerb we strive for innovation, targeted at delivering a customer-centric experience while transforming the online shopping experience. We change direction and define ourselves in the idea that individually we are incredible but united our growth is infinite and paramount to our success. iHerb strives to be the global industry leader!
iHerb is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. iHerb provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment.
