Quality Assurance

Quality and Compliance Overview

The Quality Analyst oversees and executes Quality Management Systems and compliance at the Distribution Center. They serve as a single point of contact to the Sr. Manager, Janssen Commercial Quality and Supply Chain partners on compliance-related matters and act as a liaison with multiple Quality and Compliance organizations to resolve quality and compliance issues promptly.

Responsibilities

• Review and inspect temperature monitoring devices during product receiving process, including systematic transactions in Warehouse Management System and/or SAP.
• Maintain and monitor Quarantine/Hold/Stop-Ship/Recall processes and notices.
• Manage product refusals process activities, including inspection and disposition.
• Act as the primary point of contact for Distribution Quality matters and liaise with various Quality organizations to address quality issues.
• Ensure adherence to Deviation, Corrective and Preventative Action (CAPA), and Change Control processes, collaborating with other business partners and stakeholders.
• Train new hires (FTEs) and/or contractors.
• Support 24/7 operations of the Distribution Center, monitor temperature data, and oversee Re-Pack-Re-Label processes.
• Oversee Clinical Supply Chain processes, including re-sticking and labelling activities.
• Make quality decisions based on compliance risks and business needs, evaluate overall compliance risks, recommend corrective actions, and track progress.
• Ensure compliance with local, state, federal, and international regulations and standards.
• Support New Product Launch activities, including Master Data (sIDMa) setup.
• Conduct gap assessments against Pharmaceutical Global Standards, Business processes, and External Standards.
• Identify and lead improvement opportunities and problem solutions in collaboration with Supply Chain partners.
• Develop and review SOPs, Work Instructions (WI), and other documents as needed.
• Provide data/information/metrics for Quality System Management Reviews and notify/escalate critical quality issues to management.
• Oversee the execution of Protocols and coordinate quality and compliance programs.
• Participate in internal and external audits.
• Adhere to the Training and Records Management and Retention processes.

Requirements

• A minimum of a bachelor's degree in Engineering, Life Science, Technical science, or related field is preferred, with special consideration for those with relevant background experience.
• A minimum of 2 years of experience in a highly regulated industry, particularly in Medical Device, Pharmaceutical, or Consumer products sectors, with distribution experience preferred.
• Strong communication, teamwork, problem-solving, decision-making, and root cause analysis skills.
• Experience with Warehouse Management Systems and SAP.
• Experience with Quality Management Systems such as COMET.
• Proficiency in organizational and project management skills.
• Experience with Temperature Control.
• This position may require up to 10% domestic travel.