CAPA/QMS Quality Analyst (Onsite)

Please note this is a 1 year contract position. This position is onsite in Somerset, NJ.

Qualifications / Requirements:

• Bachelor's degree in Engineering, Life Science, Technical scientific, or related discipline preferred
  • Candidates without a degree may be considered with relevant experience
• Minimum of 2 years of experience in a highly regulated industry required
• Quality and Compliance experience in Medical Device, Pharmaceutical, or Consumer Products industries preferred
• Experience in distribution operations preferred
• Strong communication, teamwork, problem-solving, decision-making, and root cause analysis skills required
• Experience with Warehouse Management Systems and SAP preferred
• Experience with Quality Management Systems such as COMET preferred
• Proficiency in organizational and project management skills preferred
• Experience with Temperature Control preferred
• May require up to 10% domestic travel

Key Responsibilities

• Manage quality and compliance product receiving process, including inspection of temperature monitoring devices and systematic transactions in Warehouse Management System or SAP
• Monitor and follow Quarantine/Hold/Stop-Ship/Recall processes and notices
• Oversee product refusals process activities, including inspection and disposition
• Serve as single point of contact to internal and external partners on Distribution Quality matters
• Adhere to Deviation, CAPA, and Change Controls processes and Quality Management Systems
• Adhere to Records Management and Retention processes
• Adhere to Training processes
• Support internal and external audits
• Plan, support, and coordinate quality and compliance programs personally
• Provide oversight for execution of Protocols
• Notify/escalate critical quality issues to management in a timely manner
• Provide data, information, and metrics for Quality System Management Reviews
• Develop and review Standard Operating Procedures (SOPs), Work Instructions (WI), and other documents as needed
• Drive innovation within functional areas while ensuring initiatives are delivered in a compliant and safe manner
• Identify opportunities to improve quality, cost, and time factors aligned with business objectives
• Communicate business issues to management, prioritize actions, and lead improvement opportunities in collaboration with Supply Chain partners
• Perform gap assessments in local procedures to global standards, business processes, and external standards
• Support New Product Launch activities at the Distribution Center, including Master Data (sIDMa) setup
• Ensure compliance with local, state, federal, and international regulations and standards
• Evaluate overall compliance risk, recommend corrective actions, and track progress
• Make quality decisions based on compliance risk balanced with business needs
• Oversee end-to-end clinical supply chain processes, including re-stickering, labeling, Re-Pack-Re-Label processes, and Batch Record/Protocol activities
• Monitor and review temperature data for the Distribution Center and ancillary areas
• Support 24/7 operations of the Distribution Center
• Operate in a team-based environment with minimum supervision
• Provide training to new hires (FTEs) and/or Contractors
• Interface collaboratively with business partners and stakeholders

Description

Responsible for the oversight and execution of Quality Management Systems and compliance.

• Serves as a single point of contact to the Sr. Manager, Commercial Quality and Supply Chain partners on compliance matters
• Liaises with multiple Quality and Compliance organizations to drive timely resolution of quality and compliance issues
• Identifies business issues and opportunities to continuously improve quality and compliance
• Leads improvement opportunities and problem solutions
• Implements and executes quality and compliance programs to ensure effective and consistent processes with established standards

Candidates must provide their phone number. Reference job number is A5177.