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Finished Product Specification Lead-8223140109
Description
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 Finished Product Specification Lead will be the Chairperson of the PSJ Committee scheduling, agendas, meeting minutes, and metrics. He/she will review and approve Product Specifications Justification and analytical methods ensuring that specifications and analytical methods are in compliance with USP, FDA, ICH, and internal guidelines. This individual will collaborate with R&D to ensure that Analytical activities with BCPs comply with applicable regulations and company requirements. The Finished Product Specification Lead will work in partnership with R&D on approval of Analytical Method Specifications. He/she will maintain up to date knowledge of industry practices. This individual will ensure compliance with cGMP's. He/she will work with R&D and Regulatory Affairs to provide compliance input on issues that may arise. The Finished Product Specification Lead will create and maintain a data base containing all products and the specification limits for Analytical Release and Stability testing. This individual will create and maintain a data base for alignment of PSJ description with MFR/NDA filing. He/she will be the approver in GSS and CONNECT for all PSJ and Analytical Method specifications. This individual will be the reviewer and approver of all Raw Material Specifications including those maintained by Consumer that are used in our Products.
The Finished Product Specification Lead will under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position ensure quality and compliance in all their actions by attending GMP training on the schedule designated for my role and as appropriate for my role. He/she will adhere to strict compliance with procedures applicable to my role. This individual will exercise the highest level of integrity in the tasks that I perform. The Finished Product Specification Lead will, in a timely and prompt manner, identify report and seek correction for deviations noted in my workplace. He/she will embrace a behavior of employee involvement and commitment to doing the job right the first time.
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, as well as create and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelors Degree in a Life Science discipline is required. A Bachelors Degree in Chemistry or Biology is preferred. A minimum of 10 years experience in a cGMP environment is required. At least 1 year of quality experience pharmaceutical, OTC and/or medical device industry is preferred. Previous lab experience is preferred. Previous experience setting and reviewing product specifications and analytical methods is required. Candidates are required to be familiar with ICH, FDA and USP regarding finished product specifications and methods. Experience with SUPAC, IPEC and other regulatory body of knowledge related to stability programs is preferred.
This role will be based in Fort Washington, PA and requires up to 10% travel.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Finished Product Specification Lead-8223140109
Description
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 Finished Product Specification Lead will be the Chairperson of the PSJ Committee scheduling, agendas, meeting minutes, and metrics. He/she will review and approve Product Specifications Justification and analytical methods ensuring that specifications and analytical methods are in compliance with USP, FDA, ICH, and internal guidelines. This individual will collaborate with R&D to ensure that Analytical activities with BCPs comply with applicable regulations and company requirements. The Finished Product Specification Lead will work in partnership with R&D on approval of Analytical Method Specifications. He/she will maintain up to date knowledge of industry practices. This individual will ensure compliance with cGMP's. He/she will work with R&D and Regulatory Affairs to provide compliance input on issues that may arise. The Finished Product Specification Lead will create and maintain a data base containing all products and the specification limits for Analytical Release and Stability testing. This individual will create and maintain a data base for alignment of PSJ description with MFR/NDA filing. He/she will be the approver in GSS and CONNECT for all PSJ and Analytical Method specifications. This individual will be the reviewer and approver of all Raw Material Specifications including those maintained by Consumer that are used in our Products.
The Finished Product Specification Lead will under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position ensure quality and compliance in all their actions by attending GMP training on the schedule designated for my role and as appropriate for my role. He/she will adhere to strict compliance with procedures applicable to my role. This individual will exercise the highest level of integrity in the tasks that I perform. The Finished Product Specification Lead will, in a timely and prompt manner, identify report and seek correction for deviations noted in my workplace. He/she will embrace a behavior of employee involvement and commitment to doing the job right the first time.
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, as well as create and maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelors Degree in a Life Science discipline is required. A Bachelors Degree in Chemistry or Biology is preferred. A minimum of 10 years experience in a cGMP environment is required. At least 1 year of quality experience pharmaceutical, OTC and/or medical device industry is preferred. Previous lab experience is preferred. Previous experience setting and reviewing product specifications and analytical methods is required. Candidates are required to be familiar with ICH, FDA and USP regarding finished product specifications and methods. Experience with SUPAC, IPEC and other regulatory body of knowledge related to stability programs is preferred.
This role will be based in Fort Washington, PA and requires up to 10% travel.
Primary Location:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Job: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.