Job Description
Responsibilities:
- 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, which can include but it is not limited to:
- Update documentation in Veeva QualityOne
- Support Change Control program
- Trend data and create monthly and quarterly KPI reports
- 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
Requirements:
- Bachelor’s degree in quality assurance, biology, chemistry, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job
- 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
Are you interested in this position?
Apply by clicking on the “Apply Now” button below!
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