HireDiversity

Fort Washington, PA, US

PRODUCT QUALITY ANALYST, COMPLAINTS (1 of 3)-9709130118

Description

McNeil Consumer Healthcare, a Division of McNeil-PPC, Inc, a member of the Johnson & Johnson family of companies, is recruiting for Product Quality Analyst, Complaints, for its location 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 Product Quality Analyst, Complaints is responsible for administration of the Customer Complaint Management System, collecting, monitoring, trending, prioritizing, coordinating investigations, and responding to customer complaints related to McNeil products in a timely manner and in compliance with Current Good Manufacturing Practices (cGMP) and McNeil Standard of Procedure (SOP) requirements.

This individual will perform initial analysis of complaints received by the site for investigation, including manufacturing and packaging records reviews, coordination of field sample inspections and retention, assessment of Notification to Management requirements and determination of expanded process SME investigation necessity.

This individual will collaborate with other complaint analysts, complaint investigators, Home Office Complaint Vigilance team, and Process SMEs to ensure thorough, robust, and timely complaint investigations. They will ensure target cycle times are met, and provide data analysis for complaint metrics and trending.

Additional responsibilities of this position include: Performing initial record reviews for complaint investigations including, but not limited to, review of deviations, manufacturing and packaging batch records, and retain samples. Prioritize complaint investigations based on risk and compliance with procedures. Determine which complaints require an expanded process SME investigation, and refer those complaints to the appropriate investigator. Determine which complaints meet Notification to Management criteria and follow the required process to notify management. Provide and analyze data as required for complaint metrics and trending, including but not limited to APRs and Site Quality Councils. Manage the inspection and retention of consumer complaint samples.

All McNeil employees are required to cultivate an environment of quality and 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 minimum of a Bachelors degree is required. A focused degree in Mathematics, Science, Engineering, or related discipline is preferred.

A minimum of 3 years of experience in the pharmaceutical industry or other highly regulated industry is required. Thorough knowledge of cGMPs and regulatory requirements/guidance are required. Experience interacting with Regulatory Health Authorities is preferred. Experience conducting and documenting investigations is required.

Strong verbal and written communication skills are required for this role. The ability to prioritize, influence, and negotiate without direct line authority is required. The ability to operate in a high pressure environment under tight time constraints, and to understand and follow complex processes is required.

Experience with SAP and Product Quality Management System (PQMS) is preferred. Experience trending in root cause analysis is preferred. Experience with Six Sigma/Process Excellence tools, training and/or certification is a plus. Experience working in a manufacturing plant is preferred. Advanced experience with Excel and Minitab is preferred.

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

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