Quality Analyst - USA (5260202)

OCASA; Miami (FL); On-site; USD 95,000 - 125,000; Full time

Job summary

OCASA is seeking a hands-on Quality Lead to oversee quality execution across our U.S. operations.

You will ensure that global quality standards, regional guidelines, regulatory requirements, and customer expectations are implemented at the local level. You will work closely with Operations, Warehouse, Transportation, Customer Service, and regional/global Quality teams to support compliance, audit readiness, and continuous improvement.

Qualifications

• Minimum 5–7 years in Quality Assurance or Quality Operations in a regulated industry.
• Experience with GDP, GMP, GxP standards and regulatory audits.
• Strong organizational and problem‑solving skills; ability to escalate risks.

Responsibilities

• Own quality activities for the U.S. operation and ensure local compliance.
• Support audits, CAPAs, deviations, change controls, investigations, and risk assessments.
• Collaborate with Operations, Warehouse, Transportation, and Customer Service to maintain quality.
• Promote a culture of quality and continuous improvement.
• Maintain QMS documentation and training records.

Skills

Quality leadership

Regulatory compliance

Audits & CAPAs

Documentation control

Cross-functional collaboration

Tools

QMS

Job description

We are looking for a hands‑on and collaborative Quality Lead to oversee Quality execution across our U.S. operations.

In this role, you will ensure that global Quality standards, regional guidelines, regulatory requirements, and customer expectations are effectively implemented and maintained at the local level. You will work closely with Operations, Warehouse, Transportation, Customer Service, and regional and global Quality teams to support compliance, audit readiness, and continuous improvement.

This is an excellent opportunity for a professional who enjoys working in a fast‑paced operational environment and wants to make a direct impact on quality performance and compliance culture.

Key Responsibilities

Quality Operations and Compliance

• Serve as the local owner of Quality activities for the U.S. operation.
• Ensure compliance with applicable regulatory requirements, customer expectations, GDP, GMP, GxP standards, and internal Quality policies.
• Support the implementation and ongoing maintenance of the local Quality Management System (QMS).
• Monitor operational processes to ensure consistency, compliance, and adherence to approved procedures.
• Manage and support SOPs, CAPAs, deviations, change controls, investigations, and risk assessments.
• Identify and **escalate** significant compliance risks to regional or global Quality leadership.

Audits and Inspection Readiness

• Maintain continuous readiness for internal, customer, and regulatory audits and inspections.
• Coordinate and support audits, inspections, and customer Quality reviews.
• Track audit observations and ensure corrective and preventive actions are completed within established timelines.
• Provide documentation and evidence required during audits and inspections.

Documentation and Quality Systems

• Ensure Quality documents and records are accurate, current, controlled, and compliant.
• Support document creation, review, approval, and periodic review processes.
• Monitor employee training compliance and maintain appropriate training documentation.
• Ensure the traceability, integrity, and availability of Quality records.

Cross‑Functional Collaboration

• Partner with Operations, Warehouse, Transportation, Customer Service, and other departments to maintain Quality compliance throughout operational workflows.
• Provide Quality support during the implementation of new customers, services, processes, or operational changes.
• Serve as a trusted advisor on Quality‑related operational decisions.
• Collaborate with regional and global Quality teams to ensure alignment with corporate standards.

Training and Quality Culture

• Promote a strong culture of Quality, accountability, and compliance throughout the organization.
• Coordinate and deliver local Quality training.
• Support Quality‑related onboarding activities for new employees.
• Encourage operational discipline, employee awareness, and continuous improvement.

Continuous Improvement and Reporting

• Monitor Quality KPIs, trends, risks, and recurring issues.
• Prepare reports that provide visibility into local Quality performance.
• Identify opportunities to improve processes, reduce risk, and strengthen compliance.
• Support corrective actions and process‑standardization initiatives.

What We Are Looking For

• Previous experience in Quality Assurance, Quality Operations, Compliance, or a related role.
• Experience working within logistics, transportation, warehousing, pharmaceutical, healthcare, clinical research, or another regulated environment.
• Knowledge of Quality Management Systems and regulated standards such as GDP, GMP, or GxP.
• Experience supporting audits, CAPAs, deviations, change controls, investigations, SOPs, and risk assessments.
• Strong organizational, documentation, and problem‑solving skills.
• Ability to work effectively with operational and corporate stakeholders.
• Strong communication skills and the confidence to identify, communicate, and **escalate** Quality risks.
• Detail-oriented, proactive, and comfortable working in a fast‑paced environment.

Why Join Us?

This role offers the opportunity to take ownership of Quality activities within the U.S. operation while collaborating with regional and global teams. You will help strengthen compliance, improve operational processes, and promote a culture in which Quality is part of every decision.