Stability Associate


McNeil Consumer Healthcare Division of McNEIL-PPC, Inc is currently recruiting for a Stability Associate - Packaging 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, Mylanta and ROLAIDS antacid products, and SUDAFED nasal decongestants.

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this individual will be responsible to ensure quality and compliance in all actions by attending Good Manufacturing Practices (GMP) training on the schedule designated for this role and as appropriate for this role. This individual must adhere to strict compliance with procedures applicable to this role. This individual must exercise the highest level of integrity in all the tasks performed. This individual will work with the team to ensure all aspects of the business remain compliant and in an audit ready state. In a timely and prompt manner, this individual will identify, report, and seek correction for deviations noted in the workplace and will embrace a behavior of employee involvement and commitment to doing the job right the first time.

The Stability Associate - Packaging will review and approve Packaging Specifications Justification ensuring that specifications are in compliance with FDA, ICH, and internal guidelines. Will collaborate with RD to ensure that Packaging activities with BCPs comply with applicable regulations and company requirements. Works in partnership with Research Development on approval of Packaging (Protocols and Reports). S/he will support investigations as needed. Maintains up to date knowledge of industry practices. The Stability Associate - Packaging will maintain compliance with cGMP's. Works with RD and Regulatory Affairs to provide compliance input on issues that may arise. Will provide Pharmacopeial Forum review. Create and maintain a database containing all products and their expiration periods and will act as approver in EDM.

Qualifications

Minimum of BS degree in Engineering, Life Sciences or related degree is required plus a minimum of 5 years of experience in the pharmaceutical or similar regulated industry. A minimum of 2 years of experience in packaging is required. Previous experience in regulatory affairs, quality assurance, operations, engineering or related field is required. Previous project management experience is preferred. Proficiency in Word, Excel and Power Point is required. Previous experience preparing reports and metric is desired. Statistical Knowledge is desired. Familiarity with ICH, cGMP, USP, SUPAC and other regulatory body of knowledge related to stability programs is preferred. Strong analytical skills required. Exceptional oral and written communication skills are required. The ability to work on cross functional teams is required. This position is located in Ft. Washington. BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson Johnson Family of Companies