Quality and Compliance Analyst
Posted Updated
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
- 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
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.