Quality Import Export Specialist

Uniphar Group•North Carolina, NC

About The Position

The Quality Import / Export Specialist provides day-to-day Quality oversight and compliance support for commercial pharmaceutical import and export activities. The role ensures activities comply with approved procedures, customer requirements, applicable regulatory requirements, and the company’s Quality Management System (QMS). Reporting directly to the US Head of Quality, the specialist is the primary Quality representative for commercial import and export operations and supports shipment review, product release, documentation review, transportation, and distribution processes in accordance with SOPs, Good Distribution Practices (GDP), Good Documentation Practices, applicable federal and state regulations, customer requirements, and the QMS. The specialist maintains active oversight of commercial import and export activities, identifies and escalates compliance risks, provides Quality guidance on shipment requirements and documentation, and collaborates with Operations, Supply Chain, Customer Service, Regulatory Affairs, freight forwarders, and customs brokers while maintaining Quality independence. The position has authority to intervene in noncompliant activities, place product, inventory, documentation, or shipments on Quality Hold, require correction or investigation, and prevent product release or shipment when requirements are unmet. Significant Quality-system decisions and certain regulatory matters remain with the US Head of Quality or a designated senior Quality representative unless formally delegated. The position is based in Garner, New Jersey, and pays $25 per hour. The posting describes a collaborative, flexible work environment and opportunities for career growth and global impact in the life sciences industry.

Requirements

Five or more years of experience in a regulated life sciences Quality Assurance environment.
Experience supporting pharmaceutical distribution, import/export operations, or GDP-regulated activities.
Experience reviewing import/export documentation and shipment records.
Experience supporting deviations, investigations, CAPAs, and Quality Management Systems.
Working knowledge of FDA-regulated pharmaceutical distribution activities.
Bachelor’s degree.
Comprehensive understanding of pharmaceutical distribution Quality requirements and Good Distribution Practices (GDP).
Strong knowledge of import/export documentation requirements and international shipment compliance.
Excellent recordkeeping skills and attention to detail.
Expertise in accurate, compliant documentation and record review.
Strong risk management, investigation, and CAPA skills.
Self-directed, with strong organizational and time-management skills.
Ability to communicate Quality and compliance expectations across cross-functional teams.
Proficiency in electronic Quality systems and standard Microsoft applications, including Outlook, Teams, and Excel.
Ability to manage multiple shipment priorities while maintaining compliance and inspection readiness.
Ability to talk and hear; frequently walk, sit, and use hands for grasping, pushing, pulling, and fine manipulation.
Ability to lift 10 pounds frequently and 25–50 pounds occasionally; occasionally drive a forklift, bend, squat, crawl, climb, and reach above shoulder level.
Ability to work around loud noises, including production and manufacturing machinery.

Responsibilities

Provide Quality oversight for commercial import and export activities within the assigned US operation.
Review import and export transactions and documentation for compliance, completeness, and accuracy, including invoices, packing lists, shipping documents, product and lot information, quantities, origins and destinations, customer details, permits, temperature requirements, and certificates.
Coordinate with Operations, Supply Chain, Customer Service, brokers, freight forwarders, and other stakeholders to resolve shipment-related Quality issues.
Verify that products, customers, destinations, and shipment activities are permitted, and ensure required Quality approvals are obtained before commercial product release.
Identify and escalate compliance risks, including risks of customs delays, product detention or refusal, regulatory violations, and customer impact.
Support investigations involving shipment discrepancies, customs holds, documentation errors, damaged shipments, temperature excursions, rejected products, and other distribution events.
Maintain records for commercial import and export activities according to retention requirements and support the development and maintenance of relevant procedures.
Review shipment records and temperature-monitoring records, and support assessments of transportation deviations and temperature excursions.
Monitor compliance for international shipments, domestic distribution of imported products, product receipt and distribution, temperature-controlled transportation, shipment release, documentation and retention, and product traceability.
Document procedural noncompliance through the QMS when required; partner with Operations and Supply Chain on recurring issues and sustainable corrective and preventive actions.
Promote Good Documentation Practices and data integrity, and support inspection readiness.
Support compliance with applicable FDA requirements, state licensing requirements, customer quality agreements, and company procedures.
Support customer and internal audits and regulatory inspections, assist with responses to findings, and monitor regulatory changes affecting import and export operations.
Initiate, investigate, review, or support deviations, occurrences, nonconformances, CAPAs, complaints, and other Quality records as assigned.
Perform root cause analysis, help develop corrective and preventive actions, monitor assigned actions through closure, and support effectiveness checks.
Create and revise SOPs, work instructions, forms, and controlled records; participate in Quality risk assessments and ensure assigned audit and inspection observations are addressed on time.
Track and trend Quality and compliance indicators, identify adverse or recurring trends, and escalate significant issues to the US Head of Quality.
Recommend improvements to compliance, efficiency, right-first-time performance, and inspection readiness; provide metrics and updates for management review and leadership reporting.
Intervene in activities that conflict with approved procedures or requirements; place product, inventory, documentation, or shipment activities on Quality Hold when warranted; require correction, escalation, or investigation; and prevent release or shipment until requirements are met.
Recommend retraining, procedural changes, CAPAs, process improvements, and additional controls based on identified Quality risks.