Quality and Compliance Analyst

Expeditors • Peabody, MA

1d • Onsite

About The Position

The Quality Management System (QMS)/Business Operations role involves monitoring and providing Quality Assurance on solutions and processes within the district. This includes creating reports, preparing internal reporting, quantifying productivity results of solutions, mapping processes to identify improvements, and performing data analysis using Expeditors system tools. The role also supports quality record keeping, develops and provides technical and quality-related training, and maintains a project ticketing system. Additionally, the position supports Good Distribution Practice (GDP) / Healthcare Quality & Compliance by assisting the Responsible Person (RP) and district employees in complying with GDP requirements, following up on compliance tasks and corrective actions, ensuring facilities and equipment meet GDP standards, supporting risk assessments, and assisting with recalled, returned, quarantined, rejected, or falsified products. The role also supports corrective and preventive action (CAPA) documentation, customer communication regarding shipment issues, appropriate transport requirements for various product types, and compliance with customer requirements. Coordination of GDP training, support for internal self-assessments and external audits, and maintenance of GDP document control and Service Provider profiles are also key responsibilities. Attendance at conference calls with the Healthcare Regional Team and departmental meetings is expected.

Requirements

• Expeditors product and service knowledge
• More than 2 years of experience within operations preferred, and/or relevant Healthcare industry experience
• GDP Certification (within 6 months of appointment)
• GDP Auditing Certification (within 6 months of appointment)
• Global logistics industry knowledge and prior knowledge related to the distribution of healthcare products
• Access to pharmaceutical knowledge and advice when required, and knowledge of the products traded under the license
• Familiarity with local regulatory requirements for wholesale distribution and the European Pharmaceutical Directive related to wholesale distribution of medicinal products
• Self-management and project management skills
• Proficient in process mapping, execution of root-cause analysis, and using problem-solving techniques
• Prior experience with communication, public speaking, and training
• Effective interpersonal skills, with the ability to relate to employees at all levels
• Strong PC and analytical skills, including experience with Microsoft Office (Excel, PowerPoint, Word), Power BI, SharePoint, and Visio
• Flowchart creation, process analysis, and auditing skills including questioning skills
• Good time management
• Fluent in English with professional oral and written communication skills

Responsibilities

• Monitor and provide Q/A on solutions and processes running in the district
• Create reports based on the needs of product and/or operational departments
• Prepare internal reporting (i.e., status and analytical reports)
• Help quantify the productivity results of each solution or tool created
• Map processes using available tools and identify improvement opportunities
• Perform data analysis using Expeditors system tools (i.e., Branch exp.o, Report Scheduler, etc.)
• Assist operations with data requirements needed to perform their daily tasks
• Maintain a project ticketing system capturing status, timeliness, and priorities and provide updates to the reporting structure for this position
• Support quality record keeping so that written procedures are documented, understood, followed and retained in compliance with OPS and local regulations
• Develop and provide technical and quality-related training for operational staff
• Develop and share AI (Copilot) solutions within the district
• Support the Responsible Person (RP), the district, and employees in complying with GDP requirements as they relate to the district facility type and GDP customer requirements
• Follow up on GDP compliance tasks and related corrective actions, employing due diligence and maintaining full compliance to procedures and appropriate regulations
• Assist in ensuring that Expeditors owned or leased facilities and equipment are maintained to GDP standards
• Support the completion and documentation of risk assessments for activities that may impact GDP or customer product
• Support operations on recalled, returned, quarantined, rejected, or falsified products as per customer instructions
• Support corrective and preventive action (CAPA) documentation so that appropriate actions are recorded and implemented correctly and on time
• Help ensure customers are informed in writing of any issues with shipments
• Support the application of appropriate transport requirements and methods for cold chain, ambient, and hazardous product, and help confirm transport equipment is appropriately qualified
• Support compliance with agreed customer requirements as documented in the Customer SOP
• Coordinate the tracking of GDP training assignments, deadlines, and refresher training in the PDC, and escalate non-compliance to the RP / District Manager
• Support internal self-assessments and help prepare for external customer or regulatory audits, and communicate results
• Support GDP document control, ensuring current-version documents are used, recorded, and retained using Expeditors systems
• Support GDP Service Provider profile maintenance in CRM per Expeditors standards
• Attend conference calls with the Healthcare Regional Team as required
• Participate in departmental and other district meetings as appropriate to discuss quality and GDP compliance

Benefits

• Paid Vacation
• Holiday
• Sick Time
• Health Plan: Medical
• Life Insurance
• Employee Stock Purchase Plan
• Training and Personnel Development Program
• Growth opportunities within the company
• Employee Referral Program Bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed