Supplier Quality Assurance Supervisor

3 weeks ago

Redmond, United States Medix™ Full time

Supplier Quality Assurance Supervisor


Pay Range: $93,500 to $130,000/yearly


Benefits: Effective the first of the month following the date of hire, employees are eligible to participate in the following employee benefit programs:

  • Medical, Dental, Vision, FSA, or HSA: Currently we contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
  • 401(k) program: We contribute 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
  • Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
  • Paid Holidays: We offer 7 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, and Christmas Day.
  • Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.


Summary:

  • Manages and effectuates all supplier evaluation and qualification activities for GMP related materials and services, in accordance with procedures (including but not limited to auditing, approval, disapproval and collaborative interface with CMOs / suppliers as relates to their qualification status.
  • Maintains the Approved Supplier List (ASL) in accordance with procedure.
  • Supports Regulatory / Clinical programming as relates to qualifying Clinical Research Organizations and related laboratories / service providers, associated with the clinical phase of the product life cycle.
  • Verifies that responsible personnel and Purchasing are adhering to the requirements of the supplier quality program, as well as the Purchasing program (IVT-SOP-ADM-001, et. al.).
  • Supports and coordinates the development and approval of material specifications for GMP-related materials intended for Phase 3 clinical or commercial use.
  • Participates in and ensure timely and effective non-conformance / complaint investigations for issues assignable to material / service providers.
  • Assures formal Quality Agreements between IVT and respective suppliers are in place and current, in accordance with approved procedures. • Posts Quality Metrics, including, but not limited to, overall supplier quality, performance tracking tracking and trending as part of the IVT Quality Metrics / Trending SOP. Further, subject metrics will be analyzed with appropriate recommendations to management.


Essential Functions:

  • Supports the Director, Incoming QC / Microbiology, in collaborating with Incoming Quality Control personnel who are responsible for testing and releasing GMP-related incoming materials.
  • Establishes and maintains supplier related data in Paradigm )or comparable QMS platform,) including but not limited to:
  • Respective supplier correspondence.
  • ASL.
  • Onsite supplier audits / responses.
  • Quality Questionnaires.
  • Supplier quality metrics reports.
  • Establishes supplemental program training materials and (together with existing related procedures) conducts on the job training (OJT) of responsible personnel.
  • Routinely collaborates with Warehouse management to ensure that quality criteria defined by the supplier program, are effectively met in the use of Netsuite (or comparable) ERP platform, used for receipt, storage and quality dispositioning of GMP-related materials. Non-


Essential Functions:

  • Ability to effectively deploy and maintain the supplier quality program using superior oral and written communication skills.
  • Performs responsibilities in accordance with project timelines, departmental goals, and budgets approved by management.

Job Specifications:

  • Proficient in MS Office Suite
  • Knowledgeable with regard to applicable regulatory requirements for supplier quality.
  • Experienced in supplier auditing and communications / project management with external parties.


Education: A B.Sc. degree in a scientific discipline required.

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