Quality and Compliance Analyst

Expeditors•Peabody, MA

2d•$55,000 - $70,000•Onsite

About The Position

The Quality and Compliance Analyst role focuses on monitoring and ensuring quality within the district's solutions and processes, particularly in relation to Good Distribution Practice (GDP) for the healthcare industry. This position involves creating reports, analyzing data, mapping processes, and supporting operational departments. The analyst will also be responsible for maintaining quality record keeping, developing training materials, and ensuring compliance with local regulations and customer-specific Standard Operating Procedures (SOPs). A key aspect of the role is supporting the Responsible Person (RP) and district management in adhering to GDP requirements, managing corrective and preventive actions (CAPA), and preparing for audits.

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.