Quality and Compliance Analyst

Job Description

Quality Management System (QMS)/Business Operations

• 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

GDP / Healthcare Quality & Compliance

• 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

Qualifications

• 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

Physical Demands

• Use of standard office equipment - computer with keyboard and mouse, phone, fax/copy/scan machine, etc.
• Write with pencil/pen/marker
• Functions performed primarily while seated at desk

Additional Information

Expeditors offers excellent 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
• Base Pay Range $55,000-$70,000 annually, based on experience

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.