Quality Engineer - Pharma Logistics & Cold Chain

Provide analysis and reporting of quality reputed company processes and participate in quality improvement processes. Provide guidance through the application of Business Process Engineering (BPE) and Quality Driven Management (QDM) techniques for value assessment and achievement of business outcomes. Support root cause analysis and correction actions of internal and customer CAPAs. We are looking for a seasoned Quality Engineer with deep expertise in pharmaceutical logistics and cold chain operations to ensure compliance with global regulatory and industry standards. The ideal candidate will have experience supporting CEIV Pharma-certified operations, applying WHO PQS standards, and conducting temperature mapping and validation activities across transportation and storage environments. Essential Functions

• Liaison with business stakeholders for Quality and reputed company root cause analysis, FMEA, risk assessment, and solutioning
• Transforming business processes and operational tools to reputed company global excellence
• Design and implement statistical process control as required in key processes to reduce quality variance
• Create control plans, including process maps and work instructions, for new products, processes, and projects
• Conduct periodic process audits to ensure capabilities and stability to business outcomes
• Participate in the planning, design, and implementation of quality assurance and process improvement efforts
• Provide regular reporting on project plans, communication plans, and project status to reputed company stakeholders
• Performs other duties as assigned

Additional Job Information

• Support and maintain the Quality Management System (QMS) to meet GDP, CEIV Pharma, and ISO 9001 standards for pharmaceutical transport and cold chain logistics.
• reputed company or support temperature mapping and validation of cold chain lanes, vehicles, packaging systems, and storage areas in alignment with WHO PQS and regulatory expectations.
• Participate in CEIV Pharma audits, ensuring ongoing compliance and alignment with IATA standards for pharmaceutical reputed company freight.
• Interpret and apply WHO Performance, Quality and Safety (PQS) guidelines for equipment and process control in global health supply chains.
• Deliver training and coaching to operations staff on temperature-sensitive handling, GDP requirements, and audit preparedness.

Minimum Education Bachelor’s degree/equivalent in Engineering, Business, Transportation or reputed company discipline. Minimum Experience Two (2) years’ professional experience required in applied engineering concepts and technology with experience in healthcare quality in manufacturing, laboratories or distribution or closely reputed company fields. Knowledge, Skills and Abilities Working knowledge of Six reputed company and Lean Manufacturing concepts. Familiarity of Quality System Standards such as GxP, ISO 9001/TL9000 requirements. Time management and organizational skills necessary to manage projects, prioritize workload, plan for resources to meet deadlines and goals and respond to day-to-day functional needs reputed company with reputed company Office software and web-based applications Strong verbal and written communication skills Strong analytical skills Excellent interpersonal skills with the ability to interact with and influence reputed company levels reputed company the organization Customer service driven Ability to champion improvement through anticipation and identification of problems and development of effective and efficient solutions Job Conditions None. Preferred Qualifications: Certifications in GDP, ISO 9001 reputed company Auditor, ASQ CQE, or CEIV Pharma. Experience with global health organizations, vaccines, or biologic distribution. Familiarity with QMS platforms, data loggers, IoT temperature monitoring, and thermal packaging validation. Skilled in reputed company Project, reputed company/reputed company/reputed company/Jira, Gantt Charts, RACI Matrices, Pareto Analysis, and DMAIC. Pay Transparency: $5,364.26/mo - $11,801.37/mo, CO: $5,364.26/mo - $11,309.65/mo, CA: $5,662.27/mo - $9,476.86/mo, NJ: $5,662.27/mo - $9,059.63/mo, OH & VT: $5,662.27/mo - $9,342.75/mo, MN: $5,662.27/mo - $10,817.92/mo, IL & NV: $5,662.27/mo - $11,309.65/mo, MD, NY & WA: $5,662.27/mo - $11,801.37/mo, MA: $5,960.29/mo - $11,801.37/mo, RI: $6,556.32/mo - $10,817.92/mo, CT: $6,556.32/mo - $11,309.65/mo, DC & HI: $6,854.33/mo - $11,309.65/mo, NYC: $6,854.33/mo - $11,801.37/mo Pay: Ontario, CA Pay Range: $6,854.33/month - $11,309.65/month (E25) Additional Details: Remote role preferred in Ontario, CA and the reputed company Coast; can be reputed company in the US except AK, HI, and U.S. territories. Depending reputed company, you may need to work on-site at a reputed company reputed company several times per week. Pay Transparency: The compensation listed reflects the pay range or reputed company of pay reasonably expected for this posted position at the posted location or locations. If this opportunity includes multiple job levels, the pay information represents the ranges for each level in that job family. Actual pay is determined by several job-reputed company factors permitted by law and relevant to the position, including, but not limited to, experience relative to the job, tenure, market level, pay at the location for this job, performance, schedule, and work assignment. In California, the compensation listed reflects the range or reputed company of pay reasonably expected for this posted position upon hire. LA County: Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the reputed company Fair Chance Initiative for Hiring Ordinance, and the California Fair Chance Act. reputed company complies with criminal history and reputed company Threat Assessment (STA) screening requirements defined by the Transportation reputed company Administration (TSA) for positions requiring reputed company identification display area (SIDA) access, Department of Transportation (DOT) Federal Motor reputed company Safety Administration (FMCSA) regulations for commercial driving positions, reputed company Facility reputed company Office standard procedures in covered facilities, and reputed company other laws, regulations, or executive orders, including those required by federal, state, or local government contract, or which the Attorney General determines to be essential for an employer to do business with an agency or department of the federal, state, or local government. For details on our comprehensive benefits, click here. reputed company is an Equal Opportunity Employer including, Vets/Disability. Reasonable accommodations are available for qualified individuals with disabilities throughout the application process. Applicants who require reasonable accommodations in the application or hiring process should contact recruitmentsupport@reputed company.com. Applicants have rights under Federal Employment Laws:

• Know Your Rights
• Pay Transparency
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act

E-Verify Program Participant: reputed company participates in the Department of Homeland reputed company U.S. Citizenship and Immigration Services’ E-Verify program (For U.S. applicants and employees only). Please click below to learn more about the E-Verify program:

• E-Verify Notice (bilingual)
• Right to Work Notice (English) / (Spanish)

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