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Lititz, PA, US

Quality Assurance Release Specialist II - 2nd Shift-0481130130

Description

McNeil-PPC, Inc is currently recruiting for a Quality Assurance Release Specialist II - 2nd Shift, located in Lititz, PA.

Johnson & Johnson has a family of companies consisting of more than 250 operating companies in 57 countries. McNeil Consumer Healthcare is the largest over-the-counter pharmaceutical company in the United States, and leader around the world. Its primary product lines include brands such as: Listerine®, Desitin®, Ben Gay®, Lubriderm® as well as others. The position is based in Lititz, PA.

The Quality Assurance Release Specialist II - 2nd Shift 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.

The Quality Assurance Release Specialist II - 2nd Shift will perform quality review of production records including manufacturing packaging, and laboratory documents. He/she will be responsible for quality releases of finished product based on conformance to established standards. The Quality Assurance Release Specialist II - 2nd Shift will participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems. Maintaining ownership of SOPs and trains colleagues on SOPs is something this individual will have responsibility for. He/she will generate, identify, and suggest quality improvements as well as improvements to quality and plant operations. The Quality Assurance Release Specialist II - 2nd Shift will be responsible for writing as well as assist others in writing new or updated operating procedures. He/she will participate and lead process improvement/cross-functional teams, as required. This individual will assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits. He/she will report improvements to management and appropriate cross-functional teams. The Quality Assurance Release Specialist II - 2nd Shift will provide real-time support to Product Manufacturing and Packaging for problem prevention/intervention and compliance improvement. He/she will also assist in Plant Audits, as required.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, The Quality Assurance Release Specialist II - 2nd Shift will ensure quality and compliance and safety in all their actions. The Quality Assurance Release Specialist II - 2nd Shift will attend GMP training on the schedule designated for the role and as appropriate for the role. He/she will adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed. The Quality Assurance Release Specialist II - 2nd Shift, in a timely and prompt manner, identifies report and seeks correction for deviations noted in the workplace. He/she will embrace a behavior of employee involvement and commitment to doing the job right the first time while modeling the Johnson & Johnson Credo. He/she will practice all behaviors in a safe and environmentally responsible manner.

J2W:LI

Qualifications


A minimum of a Bachelors Degree is required. A Bachelors Degree in Life Sciences is preferred. An Advanced Degree is preferred. A minimum of 3 years related QA or QC experience in a cGMP regulated environment is required. Previous experience reviewing and releasing batch records is also required. Quality Certifications such as CQE certification is desired. Excellent analytical, prioritization, multi-tasking and communication is required. Strong leadership skills and the ability to work independently without supervision are required. This candidate is required to work effectively on cross functional teams. Experience in a union production environment is preferred. The ability to prepare and present written and verbal reports is also preferred. SAP transactional experience is also desirable.

This position will be based in Lititz, PA and will require up to 10% travel. This is a 2nd shift role and offers no relocation.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Lititz
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
No
Travel:Yes, 10% of the time