HireDiversity

Fort Washington, PA, US

Sr. Complaint Vigilance Analyst-6439130104

Description

McNeil Consumer Healthcare is currently recruiting for a Sr. Complaint Vigilance Analyst based in Ft. Washington, PA.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.

The Sr. Complaint Vigilance Analyst will monitor and process GMS (Global Medical Safety) referrals, change logs, and GMS reconciliations. This individual will follow up with Consumer Medical Safety and GMS for clarifications associated with the referrals, change logs, and reconciliation. They will also monitor J&J security notifications for possible McNeil product impact and enter alerts into PQMS for impacted lots. The Sr. Complaint Vigilance Analyst will provide support to Complaint Vigilance process, balancing quality, business and technical considerations. This individual will execute Complaint Triage and assume the responsibilities as subject matter expert for all aspects of Complaint Triage as well as provide leadership to team of individuals responsible for the triage of complaints received daily from the Consumer Care Center. This individual will ensure quality data is provided to site complaint investigators on a timely basis to meet Notification to Management requirements. They will perform qualified approver role for records closed within Triage and also partner with site complaint investigation teams, call center, and medical group. The Sr. Complaint Vigilance Analyst will establish and implement standard processes that ensure quality targets are achieved or exceeded and will establish cycle time and right first time metrics for complaint triage. This individual will provide leadership, participation and support for any quality related investigation(s) and will perform complaint trending analysis as directed by Complaint Vigilance Management.

The Sr. Complaint Vigilance Analyst will collaborate with the Call Center to continually improve the effectiveness and efficiency of the process. This individual will investigate product quality complaints and process change log entries as assigned and will also contribute to maintenance and continual improvement of a risk management program for Complaint Vigilance. The Sr. Complaint Vigilance Analyst will develop standard metric reviews for inclusion in Senior Management and McNeil Board level presentations. This individual will establish and cultivate a robust and timely process to assure that consistent quality requirements are applied within the Complaint Vigilance network. This individual will leverage learning and best practices to Support the McNeil Site network in providing sound and timely data for initiation or inclusion in investigations related to Product Quality Complaints. They will also support Sites in data requests from Regulatory Agencies. The Sr. Complaint Vigilance Analyst will assist the Complaint Vigilance network in using tools, initiating change, and applying sound process improvement methodology and will assist in the application of appropriate controls to monitor and maintain results and foster continuous improvement.

All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.

Qualifications


A healthcare professional degree (i.e. RN) OR a Bachelors degree in Mathematics, Science, Engineering, or related discipline is required. Three years of experience with Complaint Vigilance/Pharmacovigilance systems and processes is required. It is preferred to have experience with Quality Systems, Deviation or Non-Conformance Investigations, CAPAs, Change Control and Trending Analysis/Complaint Trending. Experience working in an FDA regulated GMP environment is required. Experience with investigations is a must. Experience with computer systems is required. Proficiency with Microsoft Excel is required. Knowledge and experience with Minitab, Oracle and SAP are all preferred. ASQ Certification is a plus.

The selected candidate must have strong analytical, and leadership skills. This individual must have the ability to multi-task, communicate effectively, manage and prioritize workload for self and work effectively as a team. The ability to work accurately with time-sensitive matters of significant compliance and regulatory impact is a must. The selected candidate must have the ability to recognize areas for improvement and display the initiative and influence skills to capitalize upon them. The selected candidate must have demonstrated ability to partner across business units and functions (other J&J companies and functions) to resolve complex situations impacting McNeil.

This position is located in Fort Washington, PA and may require up to 10% travel.

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Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)