Full-Time Quality Assurance Lead
SGS is hiring a remote Full-Time Quality Assurance Lead. The career level for this job opening is Manager and is accepting Milpitas, CA based applicants remotely. Read complete job description before applying.
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The USAID Global Health Supply Chain - Procurement and Supply Management project (GHSC-PSM) procures and distributes health commodities to USAID partner countries. Focus: HIV/AIDS, malaria, maternal and child health, and reproductive health. GHSC-PSM reduces costs and increases efficiencies in global and national supply chains.
Responsibilities include forecasting and supply planning, procurement, transportation, warehousing, and in-country distribution. Supported by a strong management information system. Strengthens national supply chain systems and fosters collaboration.
Quality Assurance responsibilities include: ensuring malaria commodities comply with US Government and country requirements regarding quality, safety, and efficacy, and are suitable for intended use under the President’s Malaria Initiative (PMI) Task Order. Assist in implementing and maintaining QA/QC processes for TO2 commodities throughout the supply chain.
Additional Responsibilities:
- Periodic review/update of QA/QC SOPs for compliance.
- Review and maintain product documentation for malaria products.
- Maintain the Product Eligibility list.
- Communicate product eligibility and QA/QC requirements to other PSM functional teams.
- Lead quality investigations/non-conformances with TO2 QA/QC staff, PSM vendors, and suppliers.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) issues, liaising with the QC vendor and suppliers.
- Ensure quality incidents are reported, investigated, and resolved with Corrective Actions/Preventive Actions (CAPAs).
- Generate key performance indicator (KPI), lab performance and other reports.
- Attend PMI and other stakeholder meetings.
- Perform other QA/QC tasks as directed.
- Work effectively with internal and external QA teams (vendors, clients)
Experience and Education Requirements:
- At least 3 years of supply chain and health commodity QA experience.
- Experience with US Government projects is preferred.
- Bachelor’s degree, preferably in chemistry, biology, or a physical science.
- Understanding of and ability to apply domestic and international guidelines, policies, and regulations for malaria products.
- Ability to address technical challenges in procurement, inspection, sampling, and testing.
- Knowledge of pharmaceutical GMP and GDP requirements.
- Experience in implementing programs in low-resource settings is preferred.
Skills Strong interpersonal, communication, and attention-to-detail skills. Ability to work independently and in a team environment.