Johnson & Johnson - Fort Washington, PA

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PROCESS QUALITY SPECIALIST IV (1 of 2 positions)-1678130212


McNeil, a member of Johnson & Johnson Family of companies is currently recruiting for a Process Quality Specialist IV to be located in, Fort 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 Process Quality Specialist IV provides process expertise towards the identification, investigation and remediation of all non-conformances and provides on floor support to facilitate a state of sustained compliance and inspection readiness in manufacturing and the warehouse. Partners with other functional areas to develop and implement CAPA's, identify and drive process improvements.

The Process Quality Specialist IV will be responsible to implement effective remedial, corrective and preventive actions, assuring quality process performance and compliance with McNeil's QSR, GMP, and ISO requirements for the entire Business Unit and its manufacturing processes.

Will also support audits and inspections as SME on relevant investigations. Will be responsible to facilitate and provide indication to the functional leadership for the prioritization of projects and technical resources as needed. Provides guidance and support to resolve issues impacting timely completion and achievement of goals. Will act as a mentor and coach in functional area.

The Process Quality Specialist IV is responsible to extract and enter all commitments from regulatory documents and internal audits into the commitment tracking systems. Will also be responsible to monitor and follow up on all commitments to ensure timely completion of commitments and will be responsible to communicate deficiencies to management. This role will also be responsible to communicate and identify GMP gaps. Will participate in and act as Subject Matter Expert in all types of audits & Inspections.

The Process Quality Specialist IV will be responsible to approve CAPA Implementations, and lead the gathering of information and documentation as required for investigations or CAPAs. Will be responsible to document and thoroughly investigate all deviations, generate Quality Notices and communicate events per site procedures. Will identify all non-conformances and process failure root causes, as well as write thorough, sound and complete investigation reports

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.


A Bachelor's Degree is required, a degree in Engineering or Science is preferred. At least 5 years of experience in the pharmaceutical and/or OTC industry is required. Experience in pharmaceutical and/or OTC operations is required. Previous experience working in a quality role with emphasis on process and investigations is preferred. Active cGMP interpretation and application experience is required. Experience leading a team and/or providing guidance/direction to teammates is preferred. Thorough knowledge of cGMPs is required, knowledge of applied statistics and failure mode analysis techniques is preferred. Proficiency in preparing technical reports and presentations is required.

Candidate must have the ability to establish positive interpersonal skills and interact with people effectively, make effective decisions, take initiative and have sound judgment. Strong written and verbal communication skills are required. The successful candidate must have proven conflict management, collaboration and influencing skills, and be able to work under minimum supervision. Must be able to interact with management team at local and national level. Candidates must be an agile learner, who can manage change and work under pressure, achieving consistently high results in quality, efficiency, and compliance through individual and team efforts. Excellent planning and leadership skills are necessary.
Process Excellence/Six Sigma training or certification is desirable. This position may require working/visiting all shifts and working irregular hours.

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

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