Location: Garner, New Jersey

Pay: $25.00 per hour

About Uniphar:

Uniphar, founded in 1967, is a leading, global, full-service life sciences and healthcare services company that has grown and expanded its operations internationally across Europe, the USA, MENA and APAC. Working from clinical development to commercialization, our end-to-end services remove barriers to launch, increase access and optimize brands. Capabilities span across consulting, communications, global supply chain, regulatory compliance, medical affairs, medical communications, medical information, field (msl, sales, virtual), access, agency, research, digital, and in-licensing.

We have over 3.5K employees, $3 billion in annual revenue, over 200+ multinational partners, and deliver medications to more than 180 countries.

Uniphar US operations include integrated services from Uniphar Clinical, Uniphar Logistics, Uniphar Medical, and Uniphar Commercial including Access and Supply chain.

We deliver exceptional results driven by trust, innovation, and our patient-first culture.

Check out our EVP and why you should work for us: https://uniphar.euwest01.umbraco.io/media/44rfphln/uniphar-pharma_evp_2024_pdf_v2.pdf

US Uniphar Website: www.uniphar.us

Why Join Us?

· Competitive salary: $25 per hour

· Comprehensive benefits: health, dental, vision, 401(k) match, and more

· A collaborative, flexible work environment that supports career growth

· Opportunity to make a global impact in the dynamic life sciences industry

Role Overview:

The Quality Import / Export Specialist is responsible for providing day-to-day Quality oversight and compliance support for commercial pharmaceutical import and export activities, ensuring compliance 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 Quality Import / Export Specialist serves as the primary Quality representative for commercial import and export operations and ensures that importation, exportation, shipment review, product release, documentation review, transportation activities, and related distribution processes are performed in accordance with approved Standard Operating Procedures (SOPs), Good Distribution Practices (GDP), Good Documentation Practices (GDP/GDocP), applicable federal and state regulations, customer requirements, and the company's QMS.

The Quality Import / Export Specialist  is expected to maintain active oversight of commercial import and export activities, identify and escalate compliance risks, provide Quality guidance regarding shipment requirements and documentation reviews, and work collaboratively with Operations, Supply Chain, Customer Service, Regulatory Affairs, freight forwarders, and customs brokers to ensure Quality and compliance requirements are integrated into daily operations while maintaining Quality independence.

Essential Duties and Responsibilities:

The primary responsibilities include, but are not limited to the following:

1. Commercial Import and Export Quality Oversight

• Serve as the Quality representative for commercial import and export activities within the assigned US operation.
• Provide Quality review and oversight of commercial import and export transactions to ensure applicable regulatory, licensing, customer, product, and procedural requirements are satisfied.
• Review import and export documentation for completeness and accuracy, as applicable, including:
  • Commercial invoices
  • Packing lists
  • Shipping documentation
  • Product descriptions
  • Lot/batch information
  • Quantities
  • Country of origin
  • Country of destination
  • Customer/consignee information
  • Required permits, authorizations, notifications, or licenses
  • Temperature-control requirements
  • Certificates of Analysis
  • Certificates of Conformance
• Coordinate with Operations, Supply Chain, Customer Service, brokers, freight forwarders, and other stakeholders to resolve Quality-related shipment issues.
• Verify that applicable products, customers, destinations, and shipment activities are permitted under company procedures and applicable regulatory requirements.
• Ensure required Quality approvals are obtained before commercial product is released for importation or export.
• Identify and escalate potential compliance concerns that could result in customs delays, product detention, product refusal, regulatory violations, or customer impact.
• Support investigations associated with shipment discrepancies, customs hold, documentation errors, damaged shipments, temperature excursions, rejected products, and other distribution events.
• Ensure applicable records supporting commercial import and export activities are maintained in accordance with established retention requirements.
• Support development and maintenance of procedures governing commercial import/export Quality activities.

2. Distribution Quality and Shipment Compliance Oversight

• Review shipment records to verify compliance with approved procedures and customer requirements.
• Review temperature-monitoring records associated with temperature-controlled shipments.
• Support Quality assessment of transportation deviations and temperature excursions.
• Monitor compliance associated with:
  • International shipments
  • Domestic distribution of imported products
  • Product receipt and distribution activities
  • Temperature-controlled transportation
  • Shipment release
  • Documentation and record retention
  • Product traceability
• Ensure procedural noncompliance is appropriately documented through the QMS when a deviation, occurrence, investigation, CAPA, or other Quality record is required.
• Partner with Operations and Supply Chain personnel to identify recurring compliance issues and implement sustainable corrective and preventive actions.
• Identify emerging Quality risks before they result in regulatory, customer, product, or business impact.
• Reinforce Good Documentation Practices and data integrity requirements throughout import/export activities.
• Support inspection readiness by ensuring records and activities remain consistent with written procedures and regulatory expectations.

3. Regulatory and Customer Compliance Support

• Support compliance with applicable FDA requirements, state licensing requirements, customer quality agreements, and established company procedures.
• Review Quality documentation supporting commercial import and export transactions.
• Support customer audits, internal audits, and regulatory inspections involving import/export activities.
• Assist with responses to audit observations and compliance findings related to import/export operations.
• Maintain awareness of regulatory changes that may affect commercial import and export operations.
• Escalate significant regulatory or compliance concerns to the US Head of Quality.

4. Quality Management System Responsibilities

• Ensure activities within the Quality Import / Export Specialist's area of responsibility comply with the established QMS.
• Initiate, investigate, review, or support deviations, occurrences, nonconformances, CAPAs, complaints, and other Quality records, as assigned.
• Perform root cause analysis and assist with development of appropriate corrective and preventive actions.
• Monitor assigned CAPAs and Quality actions through timely closure.
• Identify recurring issues and recommend process improvements.
• Support creation and revision of SOPs, work instructions, forms, and controlled records associated with import/export activities.
• Participate in Quality risk assessments associated with import/export operations.
• Ensure audit and inspection observations assigned to the function are addressed within established timelines.
• Support effectiveness checks to confirm implemented corrective actions remain sustainable.

5. Metrics, Trending, and Continuous Improvement

• Track and trend Quality and operational compliance indicators, including, as applicable:
  • Import documentation errors
  • Export documentation errors
  • Shipment discrepancies
  • Customs-related holds and delays
  • Temperature excursions
  • Deviations and occurrences
  • CAPA completion
  • Customer complaints related to import/export activities
• Identify adverse trends and escalate significant or recurring issues to the US Head of Quality.
• Develop recommendations to improve compliance, efficiency, right-first-time performance, and inspection readiness.
• Provide Quality metrics and import/export compliance updates for management review and leadership reporting.
• Participate in continuous improvement initiatives while ensuring proposed efficiencies do not compromise regulatory or Quality requirements.

Quality Authority

The Quality Import / Export Specialist is authorized to:

• Intervene when an import or export activity is being performed contrary to an approved SOP, regulatory requirement, Quality requirement, customer requirement, or established product requirement.
• Place product, inventory, documentation, or shipment activities on Quality Hold when a potential compliance or product-quality concern exists.
• Require correction of documentation deficiencies prior to Quality approval.
• Require escalation and investigation of suspected deviations or regulatory noncompliance.
• Prevent the release or shipment of product when required Quality, regulatory, licensing, customer, or documentation requirements have not been satisfied.
• Escalate significant compliance concerns directly the US Head of Quality.
• Recommend retraining, procedural changes, CAPAs, process improvements, and additional controls based on identified Quality risks.

Final authority for significant Quality-system decisions, regulatory reporting, regulatory agency communications, and other matters reserved to senior Quality leadership remains with the US Head of Quality or designated senior Quality representative, unless formally delegated.

Basic Minimum Qualifications

·        Five (5)+ years 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

Education/Experience:

·        Bachelor’s degree

Ability and/or Skills:

·        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 with a high level of attention to detail.

·        Expertise in accurate, compliant documentation and record review.

·        Strong risk management, investigation, and CAPA skills.

·        Highly self-directed with strong organizational and time-management skills.

·        Skilled in communicating Quality and compliance expectations across cross-functional teams.

·        Proficient in electronic quality systems and standard Microsoft applications (Outlook, Teams, Excel, etc.).

·        Ability to manage multiple shipment priorities while maintaining compliance and inspection readiness.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk, sit and use hands for grasping, pushing, pulling and fine manipulation.. Physical duty: Medium.. Must be able to lift 10 pounds frequently and 25 - 50 pounds occasionally. Occasionally will drive a forklift. Must be able to occasionally bend, squat, crawl climb and reach above shoulder level. Will be exposed to loud noises including production and manufacturing machinery.

Equal Opportunity Employer

We recognize the right of an individual to work and to advance on the basis of merit, ability, and potential. It is our to ensure that job applicants are considered, and that employees are treated during employment, without regard to their race, color, religion, creed, sex, national origin, age, physical or mental disability, veteran status or Vietnam-Era veteran status, citizenship, marital status, domestic partnership status, familial status, gender identity, sexual orientation, legally protected medical condition (including pregnancy, childbirth, or related medical condition), genetic characteristics or other characteristic, condition or classification protected by federal, state, or local law. Uniphar is committed to the principles of equal opportunity and resolves to ensure equal opportunity in all employment practices.

Join us in shaping the future of healthcare solutions by leading innovative medical strategies that make a meaningful difference in patient outcomes worldwide!