Sr. Quality Assurance Associate - Supplier Quality

permanent

Fully Remote

Only accepting applications from: United States

Manage Supplier Quality Events: Log and investigate supplier-related Nonconformances (NCRs), conducting trend analysis and root cause investigations, coordinate Corrective and Preventive Actions (CAPAs), perform diligent follow-ups, and ensure timely, effective closure of quality actions in accordance with company procedures.
Support the Supplier Qualification Program: Maintain supplier qualification records and ensure all supplier documentation is complete, accurate, and current within the Veeva QMS Supplier Management module. Assist with supplier onboarding, qualification, periodic reviews, and requalification activities to ensure raw material suppliers, packaging component suppliers, manufacturers and warehouses consistently meet company quality, safety, and regulatory requirements.
Monitor Supplier Performance and Reporting: Generate quarterly supplier scorecards, track supplier quality metrics and performance trends, and collaborate with cross-functional teams to evaluate supplier effectiveness. Support continuous improvement initiatives by identifying opportunities to enhance supplier quality and compliance.
Support Supplier Audit Program: Help schedule and track supplier audits, document audit findings within Veeva QMS, issue Supplier Corrective Action Requests (SCARs), monitor corrective action implementation, verify evidence of effectiveness, and ensure corrective actions are adequately addressed prior to closure.
Collaborate with Supply Chain, Regulatory Affairs, Formulation, Product Development and Operations teams to resolve supplier quality issues and ensure timely QA deliverables, working as an effective member of cross-functional product teams.
Execute day-to-day QA GMP compliance activities to protect the brand while driving growth ambition.
Partner with internal and external companies to ensure appropriate QA deadlines are being met to ensure end to end quality and regulatory compliance for the business.
Assist with additional quality projects/tasks.

Experience

Bachelor’s degree in quality assurance, biology, chemistry, medical sciences, pharmacology etc.; or an equivalent combination of education and experience.
3+ years of direct US dietary supplement/food quality experience.
Knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards.
Experience with Root Cause Analysis tools to support NCR investigations to drive CAPA effectiveness.
Hands-on experience executing QA GMP compliance for a broad portfolio of dietary supplements or related products.
Applied technical knowledge to ensure GMP standards are met throughout the product life cycle.
Effective prioritization skills and the ability to execute on multiple projects, collaboratively and independently, in an agile environment.
Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external.
Strong analytical, organization and critical thinking skills.