Requisition ID: QUA008005
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Senior Specialist, Business Processes and Systems is responsible for maintaining GMP auditing business processes and systems. This role will involve the Business Owner role for the Trackwise system pertaining to Audits. The Senior Specialist will support/lead continuous improvement projects as determined by the Director to help advance the auditing organization toward improved efficiency, data integrity, etc. This includes all supporting business processes and IT systems for auditing (End to End). The position will enable the Auditing organization to meet its business objectives and goals.
The position will be responsible for developing, monitoring, trending, and reporting accurate Trackwise audit related data to understand and communicate the health of the Auditing QMS and the larger organization. The Senior Specialist must be capable of working independently with limited supervision in a virtual-management environment.
The Senior Specialist will report to the Global Businesses and Systems Lead and will collaborate with Global and Site Auditors and other relevant Merck customers to meet customer demands and advance auditing business processes.
Business System Administrator Auditing Trackwise System and related interfaces: Includes retirement (as appropriate) of systems being phased out.
Coordinate training and assign individual user access privileges in the system(s) as needed (AMS will execute IT functions for providing access) and maintain approved user access forms
Responsible for maintaining system use and administrator procedures and custodial tasks for data, including answering questions regarding data
Manage system events/issues that may come up (this will be very intensive when QSAT changes roll out through the Hypercare period
Responsible for entering all system IT Tickets/help cases and managing them through completion
Responsible for SOPs (User, System Administration, etc.)
Ability to operate effectively in a complex business environment; changing priorities, significant regulatory complexity, multiple technology platforms, etc.
Serve as Auditing Knowledge Network Steward and/or support Steward in maintaining content on the Community
Monitors system data on an ongoing basis to ensure completeness/accuracy
Assist with scheduling for Global audits to maximize effectiveness, and efficiency
Maintenance of global system for tracking auditors skills, job descriptions, resumes, and certification
Responsible for updating audit team site and ensuring content is current and relevant
Responsible for generating and reporting metrics/KPIs as needed through QSAT
Assist Auditors and sites with Regulatory Agency requests related to audits
Job: Qual Assurance & Ops Generic
Other Locations: US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck
Nearest Major Market: Philadelphia
Merck & Co., Inc.