HireDiversity

Lititz, PA, US

QA Specialist III, 2nd Shift-8741130115

Description

McNeil Consumer Healthcare is currently recruiting for a 2nd shift QA Specialist III, Release Coordinator to be based in Lititz, 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 2nd shift QA Specialist III, Release Coordinator will establish and maintain quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. This individual will perform quality review of production records including manufacturing packaging, and laboratory documents and will be responsible for quality releases of finished product based on conformance to establish standards. This individual will lead efforts to comply with company policies, procedures, and quality standards; as well as, safety and environmental regulations. They will lead Non-Conformance and CAPA investigations and develop solutions to system and procedural problems of advanced scope and complexity.

The QA Specialist III, Release Coordinator will write and assist others in writing new or updated operating procedures. They maintain ownership of SOPs and train colleagues on SOPs. In addition, they will generate, identify, and suggest improvements in significant performance trends. The QA Specialist III, will report improvements to management and appropriate cross-functional teams and will lead process improvement teams as required. They will also assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits. This individual will recommend efficiencies and improvements in Quality Release and Other Quality Systems and provides direction in problem resolution. They provide real-time support to Product Manufacturing and Packaging for problem prevention/intervention and compliance improvement and will assist in Plant Audits as required.

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 minimum of a Bachelor's Degree is required. A degree in Life Sciences or a closely related technical discipline is preferred. A minimum of 4 years of experience working in a relevant Quality function within a cGMP environment is required. Previous experience reviewing and releasing batch records is also required. Professional Quality certifications such as CQE, ASQ etc. as well as Six Sigma Process/Operational Excellence tools, trainings and/or certification are preferred.

Excellent analytical, prioritization, communication, and strong leadership skills are required. This candidate must have the ability to work independently without supervision is required. Previous 2nd shift work is preferred. The ability to work in fast paced environment with multiple priorities is a must. This candidate must be able to work effectively on cross functional teams. Experience in a union production environment is preferred. Strong influencing skills are highly preferred. The ability to prepare and present written and verbal reports to upper management and business unit heads pertaining as required is also preferred. SAP transactional experience is also desirable.

This position will be on 2nd shift and based in Lititz, PA.

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