External Manufacturing Operations Investigator Job

Job description

External Manufacturing Operations Investigator-4961150727DescriptionJohnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an External Manufacturing Operations Investigator to be located in Fort Washington, PA.Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Operations Investigator is accountable for coordinating investigations associated with various External Manufacturing Site non-conformances, and Out-Of-Specification results. This role will provide leadership to their assigned sites by leading cross functional alignment on investigations, initiating system entries, documenting nonconformance summaries and initiating action items for deviations. The Operations Investigator will review External Manufacturer’s investigation report and support documents, understand the product quality issues, gather relevant investigation information, analyze data and track the investigation progress. This role will also present documented investigation findings to EM Quality Assurance and Operations groups for approval. This individual will be responsible for tracking all open investigations at their sites, maintaining metrics and facilitating investigation discussions across J&J Consumer Inc. and External site. Individual will be responsible for adherence to the investigation process and the time constraints set forth by the business. The Operations Investigator will drive and provide expertise in resolution of roadblocks that prevent optimal effectiveness of the investigation process; and will work with other corporate units 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.
QualificationsA minimum of a Bachelor's Degree is required. A focused degree in Scientific, Engineering or a closely related Technical discipline is preferred. A minimum of 4 years relevant professional experience in a GMP regulated environment (pharmaceutical etc.) is required; prior experience with documented investigations is preferred; technical writing background is preferred. Experience with pharmaceutical manufacturing (processing/packaging, etc.) is required. Experience with facilities, validation, analytical sciences, microbiology or engineering is preferred. It is required to have a thorough understanding of compliance requirements (cGMPs, etc.). This individual must have the ability to handle multiple complex investigations at one time. The ability to read, analyze and interpret common scientific and technical documents is required. Organizational skills and the ability to adapt to a fast-paced environment with changing priorities are required. The ability to effectively present information and communicate clearly with all levels of management is required. The ability to work directly with internal partners and external manufacturing sites under limited supervision is required. Demonstrated knowledge of computer systems (i.e. – nonconformance systems such as ETQ, etc.) and Microsoft Office skills is preferred. Individual should demonstrate the following: ability to drive and facilitate cross functional meetings, detail and goal oriented, work in a team environment, customer focus, ability to manage multiple projects, prioritize and adapt to business needs, effective verbal and written communication skills, interdependent partnering, strong decision making/analysis skills are required.
This position will be based in Fort Washington, PA and may require up to 10% travel in domestic and international.
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J2W: LI NAPrimary Location:North America-United States-Pennsylvania-Fort WashingtonOrganization: J & J Consumer Inc. (6101)Job Function: Quality ControlCertain 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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement