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Fort Washington, PA, US

Quality Assurance Associate II - Retain Room-8856130116

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Quality Assurance Associate II, Retain Room 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 QA Associate II will be responsible for leading the activities that pertain to the collection, storage, maintenance and ultimately destruction of retain samples in accordance with McNeil policies and procedures and regulatory agencies. This individual will coordinate with and support the Quality Systems group by providing required information relating to retention samples for the annual product review reports. The QA Associate II ensures that the environmental controls of the retain area are functional and operational. Responds, evaluates and if applicable, escalates environmental excursions to QA management. They will also support area-related investigations. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Engineering, Maintenance and other departments as it relates to Retain Room responsibilities and will ensure compliance with the Good Manufacturing and Documentation Practices.

The QA Associate II - Retain Room will provide guidance on daily activities and priorities to Retain Room QA Technician in a manner that adheres to the requirements of the area applicable procedures. This individual will receive and collect retain samples (Chemical Raw Materials, Packaging components, finished product) provided departments: Sampling and Inspection, packaging, and other departments as applicable. Logs samples in the retain samples log books and or appropriate electronic systems. They will also ensure the retention samples are stored under the temperature and relative humidity specified conditions. The QA Associate II will perform Annual Visual Inspection as per triggers identified by AVI procedure and issue results in the form of memos or reports to appropriate departments (example APR group). They will also report to QA management any discrepancy or trend(s) found during the execution of the Retain Room activities. This individual will perform activities as per applicable Retain Room procedure for the identification and destruction of expired retain samples.

The Quality Assurance Associate II - Retain Room, will adhere to procedural requirements for the receipt, storage and destruction of listed products in addition to procedural requirements for the receipt, storage and destruction of recalled product. This individual will perform activities pertaining to Retain Room inventory verification and will perform other activities as deemed necessary to ensure adherence of the Retain Room with McNeil policies and procedures and regulatory and as deemed necessary by QA management. This individual will provide support to Investigations and/or Investigation Protocols, pertaining to the area as well as to the Consumer Complaint retention program. The QA Associate II will provide QA support to various project teams, as needed. This individual will also Generates monthly, quarterly and on demand reports on time as applicable and as required by procedures.

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 focused degree in Science or a closely related technical discipline is preferred. A minimum of 2 years of relevant Quality experience within the OTC and/or Pharmaceutical industry is required. Active cGMP interpretation and application experience is required. Previous Investigation experience is preferred. Process and systems experience, specifically SOPs, MBRs, Change Controls, is highly preferred.

Previous experience leading a team and/or other individuals is preferred. Six sigma Process Excellence tools, training and/or certification is a plus. This candidate must have strong organizational, communication/interpersonal and facilitation skills (verbal, written and presentation). This candidate must have excellent problem solving skills and must demonstrate expertise in handling multiple priorities simultaneously.

This position will be based in Ft. Washington, PA and may require minimal travel.

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-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
Yes - Within Country