Quality Assurance Supplier Specialist - Santa Cruz, CA

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Job Description

Position Summary:

The Quality Assurance Supplier Specialist will interact with cross-functional groups such as Quality Control, Supply Chain, R&D and Sales to ensure approved quality systems are established and maintained. This position will be responsible for Supplier Qualifications, Supplier Risk Assessments, Supplier conformance of raw ingredients. Supplier onsite auditing will be required. Data collection and maintenance of supplier electronic records into databases.

Key Activities:

  • QA oversight of the supplier qualification program
  • Develop and maintain Foreign Supplier Verification Program per 21CFR117
  • Develop annual supplier audit schedule and request supplier audits and/or information as needed
  • Lead supplier quality audits to assure the quality of incoming materials and services as necessary
  • Track supplier reassessment dates and update approved supplier database
  • Manage and strengthen SCAR (Supplier Corrective Action Request) program
  • Assist in the investigation of raw material/component non-conformance
  • Work with suppliers to develop and create supplier quality agreements
  • Support internal inspection activities (walkthroughs, readiness activities, etc) as needed
  • Understands and follows GMP/GLP regulations
  • Keeps abreast of current GMPs and current advances in the FDA and other regulatory agencies
  • Assists in the development or edit of new/revised standard operating procedures, forms, specifications, etc
  • Perform training on QA system SOPs as required
  • Be an active participant in the Regulatory audit team and participate in regulatory audits
  • Proactively and continuously improves internal processes with a quality mindset
Required Qualifications:
  • Associates Degree or Bachelor’s Degree preferred
  • GMP compliance and Part 110,111 and FSMA compliance knowledge preferred
  • GFSI, BRC, SQF Practitioner, PCQI, FSMA and PCQI knowledge preferred
  • 1+ years working experience as an Internal Regulatory/Quality Auditor preferred
  • 1+ years Industry experience in Dietary Supplement, Food Manufacturing, Pharmaceuticals preferred
  • Ability to work in a fast-paced, team environment
  • Excellent written and verbal skills
  • Strong attention to detail

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Posted: Jan 21, 2019

Type: Full Time

Category: Quality SQF HACCP Assurance GMP