Quality Assurance Lead

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Job Description

The USAID Global Health Supply Chain - Procurement and Supply Management project (GHSC-PSM) procures and distributes health commodities to USAID partner countries. The focus is on HIV/AIDS, malaria, maternal and child health, and reproductive health. GHSC-PSM works to reduce costs and increase efficiencies in global and national supply chains. GHSC-PSM is responsible for forecasting and supply planning, procurement, transportation and warehousing, and in-country distribution, supported by a strong management information system providing accurate real-time data. Also, the project strengthens national supply chain systems and fosters collaboration among supply chain stakeholders worldwide. 

We seek a highly motivated, experienced Quality Assurance Specialist who will work as a member of the PSM Malaria Quality Assurance (QA) team that ensures that malaria commodities procured and distributed with financing from the US Presidents Malaria Initiative (PMI) comply with United States Government and country requirements regarding quality, safety, and efficacy and are suitable for their intended use.  

• Under the leadership of the PSM Malaria Quality Assurance and Quality Control (QA/QC) Manager, assist in implementing health commodity quality QA/QC processes under the President’s Malaria Initiative (PMI) Task Order (TO2).
• Assist in ensuring that QA/QC processes for TO2 commodities are adhered to and maintained throughout the supply chain.
• Perform periodic review/update of all QA/QC standard operating procedures (SOPs) to ensure compliance with applicable current national/international requirements/practices (i.e. regulatory GDP/GSP requirements, compliance with evolving innovations, addition of new products/specifications etc.).
• Review and maintain appropriate product/dossiers supporting documentation for procuring and distributing malaria products {i.e., antimalarial medicines, malaria Rapid Diagnostic Tests (RDTs) and Long Lasting Insecticide Nets (LLINs)}.   
• Maintain Product Eligibility list by ensuring that it is up to date, and each product has applicable PMI specified QC (inspection, sampling and testing) requirements. 
• Ensure the eligible products and the respective QA/QC requirements are adequately communicated to and understood by other PSM functional teams (Procurement, Strategic Sourcing, Deliver/Return etc.) so they can be incorporated into their processes/SOPs as applicable. 
• Lead quality related investigations/non-conformances in collaboration with the TO2 QA/QC staff and PSM vendors/suppliers. Lead quality related investigations such as out of specification (OOS) and out of trend (OOT), including liaising with GHSC-PSM QC vendor (i.e., testing lab) and supplier.
• Ensure quality related incidents such as out of specification (OOS) and out of trend (OOT) are properly reported by the vendors/suppliers and investigated thoroughly with root cause analysis report and applicable Corrective Actions/Preventive Actions (CAPAs) are identified and implemented to resolve the current incident and avoid reoccurrence.  
• Generate key performance indicator (KPI), lab performance and other reports as required.
• Attend and represent TO2 QA Team at routine meetings with PMI and other internal and external stakeholders as required. 
• Perform any other QA/QC related tasks as directed by the PSM Malaria QA/QC Manager.
• Ability to work effectively with internal GHSC-PSM teams and external QA teams including but not limited to vendor and client QA teams.

Qualifications

• At least three years of experience working in supply chain and health commodity Quality Assurance, experience with US Government projects is an added advantage. 
• Bachelor’s degree, preferably in chemistry, biology or a physical science.  
• Understanding of and ability to apply domestic and international guidelines, policies, and regulations regarding the quality, safety, efficacy and use of malaria pharmaceutical products, LLINs and malaria RDTs.
• Ability to address the technical challenges in procuring, inspecting, sampling and testing the above products.
• Knowledge of and experience with pharmaceutical GMP and GDP requirements.
• Ability to lead product out of specification investigations and problem-solving meetings.
• Experience in implementing programs in low-resource settings is an added advantage.
• Excellent interpersonal, written, and oral communications skills.
• Flexible and able to work both independently and in a team.
• Attention for detail.

Additional Information

Benefits

• Competitive salary.
• Comprehensive health, dental, and vision insurance for full time employees.
• Retirement savings plan.
• Continuous professional development and training opportunities.
• A dynamic, collaborative work environment.
• Access to cutting-edge cryptographic technology and tools.

Physical Demands of the Job

• Stand: Occasionally
• Move or traverse: Frequently
• Sit: Constantly
• Use hands: Constantly
• Reach with hands and arms: Occasionally
• Climb or balance: Occasionally
• Stoop, kneel, crouch or crawl: Occasionally
• Talk/hear: Constantly
• Taste/Smell: Occasionally
• Lift/carry/push or pull: Occasionally 30 lbs

Additional information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a callback.  Please note, this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.