Analyst - Quality Assurance

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title:

Analyst 2 - Quality Assurance.

Location:

Shepherdsville, KY.

Job Description:

• 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 Quality Management Systems.
• Responsible for adherence to the Records Management and Retention processes.
• Responsible for adhering to the Training process.
• Supporting internal and external audits.
• Plans, support, and coordinates quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the duties personally.
• Provide quality and compliance oversight for execution of Protocols.
• Notify/escalate critical quality issues to management in a timely manner.
• Provide data/information/metrics to management for Quality System Management Reviews.
• Develop and review of Standard Operating Procedures (SOPs), Work Instructions (WI) and other documents, as needed.
• Drives innovation within functional areas while ensuring functional initiatives are delivered in a compliant and safe manner.
• Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Janssen Commercial Quality and DELIVER Supply Chain business objectives.
• Identify business issues, communicates to management, prioritizes for action, and leads improvement opportunities and problem solutions in collaboration with other Supply Chain partners.
• Perform gap assessments in local procedures to Pharmaceutical Global Standards, Business processes, and External Standards.
• Support of New Product Launch activities at the Distribution Center, including, but not limited to Master Data (sIDMa) set-up.
• Ensures compliance and remaining current with local, state, federal, and international regulations and standards.
• Evaluate the overall compliance risk and recommending corrective actions and tracking progress.
• Responsible for making quality decisions based upon assessments of compliance risks balanced with the overall business needs.
• Compliance oversight for the end-to-end clinical supply chain processes, including, but not limited to re-stickering and other labeling activities.
• Compliance oversight for the end-to-end Re-Pack-Re-Label processes, including, but not limited to Batch Record/Protocol activities.
• Monitor and review temperature data for the Distribution Center and ancillary areas.
• Supports 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 other business partners and stakeholders.

• 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…