Quality Assurance

Katalyst CRO; New Jersey; On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Quality Analyst to oversee Quality Management Systems at the Distribution Center and liaise with Janssen Commercial Quality and Supply Chain partners on compliance matters.

The role focuses on quality and compliance programs, CAPA, change controls, and ensuring adherence to global regulations, including temperature controls, batch records, and audit support. 24/7 operations support and training provided.

Qualifications

• Bachelor's degree in Engineering, Life Science or related technical discipline is preferred.
• 2+ years in a regulated industry with quality/compliance exposure is expected.
• Experience with SOPs, CAPA, change control and audits is preferred.

Responsibilities

• Oversee and execute Quality Management Systems and compliance at the Distribution Center.
• Serve as liaison with Janssen Commercial Quality and Supply Chain partners on compliance matters.
• Lead CAPA and change control processes; drive corrective actions and track progress.

Skills

Communication skills

Teamwork

Problem solving

Root cause analysis

SAP

WMS

Education

Bachelor's degree in Engineering, Life Science or related technical field

Tools

SAP

Warehouse Management System (WMS)

Job description

Summary

The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

• Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP
• Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices
• Product refusals process activities, including, but not limited to inspection and disposition
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and
• Interface collaboratively with other business partners and stakeholders
• Provide training to new hires (FTEs) and/or Contractors
• Operate in a team-based environment with minimum supervision
• Supports 24/7 operations of the Distribution Center
• Monitor and review temperature data for the Distribution Center and ancillary areas
• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities
• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labelling activities
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs
• Evaluate the overall compliance risk and recommending corrective actions and tracking progress
• Ensures compliance and remaining current with local, state, federal, and international regulations and standards
• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up
• Perform gap assessments in local procedures to Pharmaceutical Global Standards, Business processes, and External Standards
• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner
• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed
• Provide data/information/metrics to management for Quality System Management Reviews
• Notify/escalate critical quality issues to management in a timely manner
• Provide quality and compliance oversight for execution of Protocols
• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally
• Supporting internal and external audits
• Responsible for adhering to the Training process
• Responsible for adherence to the Records Management and Retention processes

Summary

The Quality Analyst is responsible for the oversight and execution of Quality Management Systems and compliance at the Distribution Center. The Quality Analyst serves as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance related matters and is the liaison with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance related issues. The Quality Analyst identifies business issues, identifies opportunities to continuously improve quality and compliance and leads improvement opportunities and problem solutions. The Quality Analyst implements and executes quality and compliance programs to ensure effective and consistent processes with established standards.

Roles & Responsibilities

• Quality and compliance product receiving process, including, but not limited to receiving inspection activities such as review of temperature monitoring devices and systematic transactions in Warehouse Management System and/or SAP
• Monitoring and following Quarantine/Hold/Stop-Ship/Recall processes and notices
• Product refusals process activities, including, but not limited to inspection and disposition
• Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues
• Responsible for adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and
• Interface collaboratively with other business partners and stakeholders
• Provide training to new hires (FTEs) and/or Contractors
• Operate in a team-based environment with minimum supervision
• Supports 24/7 operations of the Distribution Center
• Monitor and review temperature data for the Distribution Center and ancillary areas
• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities
• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labelling activities
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs
• Evaluate the overall compliance risk and recommending corrective actions and tracking progress
• Ensures compliance and remaining current with local, state, federal, and international regulations and standards
• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up
• Perform gap assessments in local procedures to Pharmaceutical Global Standards, Business processes, and External Standards
• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner
• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed
• Provide data/information/metrics to management for Quality System Management Reviews
• Notify/escalate critical quality issues to management in a timely manner
• Provide quality and compliance oversight for execution of Protocols
• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally
• Supporting internal and external audits
• Responsible for adhering to the Training process
• Responsible for adherence to the Records Management and Retention processes

Education & Experience

• A minimum of bachelor's degree in an Engineering, Life Science, and Technical scientific or related discipline is preferred. In absence of a bachelor's degree, special consideration would be considered for individuals who have related and background experience.
• A minimum of 2 years of experience in a highly regulated industry is required.
• Quality and Compliance experience in the Medical Device, Pharmaceutical or Consumer products industry and experience in distribution is preferred.
• Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required.
• Experience with Warehouse Management Systems and SAP is preferred.
• Experience with Quality Management Systems such as COMET is preferred.
• Proficiency in organizational and project management skills is preferred.
• Experience with Temperature Control is preferred.
• This position may require up to a 10% of domestic travel.