Senior Quality Assurance Manager
Since 1996, the foundation of iHerb, has continued its mission, built on providing a wide selection of health and wellness products to individuals around the globe at a reasonable cost. iHerb remains vigilant in its pursuit to ensure it maintains an expansive selection of over 35,000 online products to its customers. We are continuously innovating and expanding, committed to adding distribution centers around the world. Our vision is to be the dominant health and wellness
iHerb is a fast paced, fast growing company looking for a candidate that is up for the task! Our Customer Experience Specialists are energetic, looking to grow with the team, and are able to communicate effectively with our valued customers and other departments!! If you are looking to really make a position for yourself in a work hard, play hard atmosphere, make sure to submit your resume!
- Develop, implement, and maintain quality process/systems and drive continuous improvement.
- Lead regulatory compliance to domestic/international regulations, product quality, and food safety.
- Understanding industry domestic regulations (FDA, OTC, 21CFR, FSMA) and global regulations that could impact our products.
- Manage all internal and external audits and summarize and create technical reports of inspection/audit findings.
- Collaborate with Supply Chain and Product Development Leads to assess raw materials for reformulation initiatives and/or ingredient substitutions.
- Manage iTested program and serve as QA subject matter expert for internal GMP operations as well as in the resolution of out-of-specification investigations.
- Ensure suppliers food safety and quality practice compliance and all relevant documentation and programs are managed and maintained.
- Manage Vendor Qualification Programs and continuously monitor their status and maintain performance metric.
- Support Manufacturers and Supply chain to manage finished product compliance.
- Manage product withdrawals and execute recall events and completion of related documentation.
- Establish and ensure specifications for raw materials, components, works-in-progress, and finished goods align with state and federal regulations, including labeling requirements.
- Manage consumer satisfaction measures (i.e. customer reviews), document control, release and stability testing program, root cause problem solving, and new product quality assurance.
- Understand product workflow; follow product from start to finish, ensuring finished goods meet written expectations/specifications. Review design process of finished goods as it relates to customer specifications
- Review and verify labels for compliance.
- Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
- Strong analytical, problem solving, data management, and follow up skills
- Ability to communicate written and verbally in a professional manner with people at all levels of the organization and external contacts
- Time management and prioritization skills, ability to multi-task in a fast-paced environment
- Ability to proactively identify challenges and develop solutions
- Detail oriented, strong analytical skills, team-player
- Strong MS Office skills including intermediate level Excel skills
- Strong knowledge of FDA 21 CFR Part 111, FSMA, FSVP, DSHEA, HACCP, cGMP guidances, and other regulatory practices.
- 5+ years of relevant industry experience in R&D, Manufacturing, Quality Assurance and/or Regulatory Affairs
- Certified Auditor
- PCQI certified a plus
- Bachelor’s Degree in Food Science, Microbiology, Chemistry or related field preferred, or a combination of education and equivalent work experience.