Quality Coordinator

Job Title: Quality Coordinator
Job Type: Contract
Duration: 6 months
Location: Kearny, NJ 07032
Hours: M-F 7am - 4:30pm

Reporting Structure
Reports To: Regional Quality Manager

Position Overview
The Quality Coordinator / Quality Representative is responsible for supporting and maintaining quality and compliance activities at the local level within the Transport and logistics operations. This role ensures adherence to internal policies, quality standards, regulatory requirements, and customer expectations.
The Quality Coordinator serves as a key point of contact for quality-related matters and provides guidance and support to operational teams. The role also supports Quality Management System (QMS) activities, audits, supplier qualification, incident management, compliance monitoring, training, and continuous improvement initiatives.

Key Responsibilities:
Quality Management System (QMS)

• Support the development, implementation, and maintenance of the Quality Management System (QMS).
• Maintain quality policies, procedures, SOPs, work instructions, and performance metrics.
• Serve as a key contact for local management and employees regarding quality-related matters.
• Ensure quality requirements are appropriately represented during local and global meetings, projects, and initiatives.
• Organize and support management review meetings in accordance with applicable SOPs.
• Ensure quality-related documentation is maintained, reviewed, and updated as required.

Supplier Qualification and Quality Agreements

• Support the Supplier Evaluation and Qualification Program in accordance with internal guidelines.
• Review and evaluate local suppliers and subcontractors for approval or rejection.
• Collaborate with subject matter experts and operational teams to ensure suppliers meet required quality standards.
• Participate in supplier audits, performance monitoring, and corrective action activities.
• Review quality agreements, confidentiality agreements, and related documentation to ensure alignment with internal and regulatory requirements.

Audits, Inspections, and Certification

• Act as a key contact for internal, external, regulatory, customer, and certification audits.
• Coordinate audit activities and communicate with relevant internal stakeholders and auditors.
• Provide requested documentation, information, and clarification in a timely manner.
• Support the development and implementation of action plans to address audit findings and non-compliance issues.
• Monitor corrective actions and ensure audit responses are completed within required timelines.
• Participate in self-inspections and routine quality checks as required.

Incident, Deviation, and CAPA Management

• Review and maintain documentation related to incidents, deviations, and non-conformances.
• Participate in investigations and provide quality input for root cause analysis.
• Support Corrective and Preventive Action (CAPA) activities to address identified issues.
• Monitor deviations, action plans, and follow-up activities according to internal procedures.
• Prepare and maintain investigation reports and supporting documentation.
• Escalate significant quality issues or potential compliance concerns to Quality Assurance and local leadership.
• Support the effective investigation and resolution of relevant customer complaints.

Risk Management and Change Control

• Participate in risk management and change control processes.
• Assess the potential quality and compliance impact of operational changes.
• Support communication with customers regarding applicable changes, including facility expansions, relocations, operational changes, and regulatory updates.
• Ensure appropriate documentation and approvals are completed before implementing changes.

Technical Quality and Facility Support

• Support technical change controls, calibration, maintenance, qualification, and validation activities.
• Assist with facility and technical compliance activities in accordance with internal guidelines.
• Review temperature monitoring data and temperature graphs as required by applicable SOPs.
• Ensure pest control and facility cleaning programs are implemented, documented, and maintained appropriately.

Documentation and Data Management

• Ensure accurate and complete documentation of quality-related activities.
• Maintain SOPs, work instructions, audit records, test records, investigation reports, and other quality documentation.
• Coordinate regular reviews of local SOPs and work instructions with process owners.
• Ensure documentation aligns with internal standards, customer requirements, and applicable regulations.
• Use quality management and document management systems, including MasterControl, SharePoint, or similar tools.
• Enter, update, track, and maintain quality data and supporting documents accurately and on time.

Quality Control and Compliance

• Perform quality checks and monitoring activities to ensure service and operational requirements are met.
• Review records and data for accuracy, completeness, and compliance.
• Identify defects, gaps, deviations, and opportunities for improvement.
• Ensure compliance with applicable local laws, GDP, GxP, ISO standards, quality regulations, customer requirements, and internal policies.
• Stay informed about changes in regulations and support the implementation of necessary QMS updates.
• Monitor employee adherence to applicable policies and procedures.
• Ensure required licenses, permits, and regulatory documentation are current and properly maintained.

Quality Training and Education

• Support the development and implementation of quality training programs.
• Train employees on quality standards, documentation practices, quality processes, and compliance requirements.
• Support initial and ongoing training related to Good Documentation Practices, Good Manufacturing Practices, Good Distribution Practices, and Good Clinical Practices, where applicable.
• Maintain local training job codes and training matrices in collaboration with local management.
• Monitor training completion and compliance and escalate overdue or non-compliant training as necessary.

Continuous Improvement and Customer Satisfaction

• Identify opportunities to improve quality and operational processes.
• Analyze quality data and evaluate existing workflows to identify areas for improvement.
• Participate in continuous improvement initiatives and applicable Lean or Six Sigma projects.
• Support client meetings and monitor customer feedback and satisfaction.
• Collaborate with operational teams to improve service quality and customer experience.

Additional Responsibilities

• Maintain appropriate records of delegated duties and responsibilities.
• Perform assigned quality responsibilities in accordance with delegation plans and internal procedures.
• Support Regional and Global Quality Management teams as required.
• Ensure applicable national and local regulatory requirements are followed.
• Perform other quality and compliance responsibilities as assigned.

Required Qualifications

• Diploma or Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences, Quality Management, Logistics, Engineering, or a related field.
• 0-2 years of experience in quality assurance, quality control, compliance, logistics, pharmaceutical, healthcare, or a related regulated environment.
• Basic understanding of Quality Management Systems and quality processes.
• Knowledge of GDP, GMP, GCP, GxP, ISO, or other applicable quality standards is preferred.
• Basic understanding of audits, CAPA, deviations, risk management, and change control processes.

Required Skills and Competencies

• Strong verbal and written communication skills in English and the local language.
• Ability to communicate clearly and professionally with internal teams, customers, suppliers, and external stakeholders.
• Strong attention to detail and organizational skills.
• Ability to manage multiple tasks and prioritize work effectively.
• Strong sense of integrity, accountability, and transparency.
• Ability to work independently while also collaborating effectively with cross-functional teams.
• Strong problem-solving and analytical skills.
• Customer-focused mindset with an understanding of business and operational requirements.
• Self-motivated, dependable, and committed to completing tasks within established deadlines.
• Advanced proficiency in Microsoft Office, including Excel, Word, and PowerPoint.
• Experience with MasterControl, SharePoint, or other quality management/document management systems is preferred.

Experience Level
Quality Coordinator - Entry Level

• 0-2 years of relevant quality or compliance experience.
• Able to make basic quality-related decisions with appropriate supervision.
• Works under the guidance and support of a line manager or senior Quality professional.
• Key quality documentation and decisions may require review and approval by the Quality Manager.

Work Environment:
The employee may work in an office, operational, warehouse, transport, or logistics environment. Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.