Analyst - Quality Assurance

Hi, My name is Avery, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Quality Assurance Analyst for a prominent client of ours. This position is located in Shepherdsville, KY or Somerset, NJ. Details of the position are as follows:

• Pay: $40-45/hr to Start!!
• 12-month assignment, possibility for extension or conversion based on performance and budget.
• Mon – Fri (10% Travel)
• The position will mainly be responsible for quality and compliance product reviewing 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
• The position will monitor and follow Quarantine/Hold/Stop-Ship/Recall processes and notices
• The position will perform product refusal process activities, including inspection and disposition.
• The position will serve as a 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.
• The position will be responsible for the adherence to the Deviation, Corrective and Preventative Action (CAPA), and Change Controls processes and Quality Management Systems
• The position will be responsible for adhering to the Records Management and Retention process
• The position will support internal and external audits.
• The position will support, plan, and coordinate quality and compliance programs designed to ensure effective and consistent processes with established standards by performing duties personally.
• The position will provide quality and compliance oversight for execution of protocols
• The position will develop and review Standard Operating Procedures, Work Instructions and other documents as needed.
• The position will support New Product Launch activities at the Distribution Center including Mater Dara (sIDMa) set up
• The position will ensure compliance and evaluate the overall compliance risk and recommend corrective actions
• The position will provide compliance oversight for the end-to-end clinical supply chain processes and provide compliance oversight for the end to end re-pack-re-label processes
• The position will support 24/7 operations of the distribution center and provide training to new hires

• High School Diploma or Equivalent Required!
• 2+ years of experience in a regulated industry Required!
• Quality and Compliance experience in the Medical Device, Pharmaceutical, or Consumer products industry and experience in distribution Preferred!
• Experience with Warehouse Management System and SAP Preferred!
• Experience with Quality Management Systems such as COMET Preferred!
• Experience with temperature control Preferred!

If you are interested in hearing more about the position, please respond to this post with your resume attached or contact me at

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