Compliance Investigator

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Job Description:

The Compliance Investigator will provide Issue and CAPA support to the Logistics Branches. This position will be in charge of opening, completing the impact assessment, investigating, entering the action plan, doing the effectiveness check of the issues where the investigating site or site issue occurred is MIA-LOG. They will be responsible to prepare and manage CIR (Client Issues Report), follow up issues and CAPAs and monitor the metrics.

Main Duties and Responsibilities

• Act as a lead investigator. Open issues and compete the impact assessment. Perform root cause analysis, close deviations, and effectiveness checks.
• Provide guidance on investigations to co-investigators and operational staff, as well as participate in global quality sessions on investigations.
• Issue escalation and mitigation. Identify trends within the investigations team and report findings to management and quality logistics staff.
• Create and expedite Client Incident Report (CIRs)- Investigation summary reports for the clients. Actively participate in calls with customers.
• Assist with CAPA completion as a CAPA owner and identify and suggest robust Corrective and Preventative Actions. Analyze and highlight issue and CAPA trends. Support assignment of proper corrective actions.
• Define and execute training to improve understanding of and compliance with procedures and quality requirements.
• Collaborate with Marken Vendor and Logistics Service Provides to complete investigation and CAPAs.
• Track and communicate process improvements in the region including Standard Operating Procedures.
• Lead and facilitate regional continuous improvement events with the operational excellence team.
• Perform calculation, data collection in support of Marken operations, global initiatives, and management reviews.
• Identify inconsistencies and/or deficiencies in the QMS and report them to the Branch Management and Quality Logistics staff.
• Work closely with local quality coordinators, Quality Managers and Directors.
• Support other Quality Coordinators' activities as needed.
• Perform weekly metrics on CAPA system (number of issues and CAPAs completed per week, number of issues completed overdue, issues effective versus ineffective).
• To do weekly follow up of the issues and CAPAs.

Qualifications:

• Bachelor's degree or the equivalent combination of relevant education and professional experience
• 2 years of relevant experience, including Quality and Logistics experience
• Knowledge and understanding of GDP and ISO Compliance
• Pharmaceutical/biotechnology industry experience is preferred
• Logistics and / or Project Management experience is preferred
• Intermediate level experience with Microsoft Office Suite (Outlook, Word, Excel)

Marken, UPS Healthcare Precision Logistics (formerly Marken, MNX & Polar Speed), the clinical and advanced therapy subsidiary of UPS Healthcare, unites expertise across healthcare and complex secure logistics to drive the success of our clients through innovation.

Employee Type:

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

Other Criteria:

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law.

Basic Qualifications:

Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.