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Quality Systems and Quality Control Coordinator

Company: Johnson & Johnson
Location: Draper
Posted on: June 5, 2021

Job Description:

Zabree's part of Johnson & Johnson Consumer Inc. is recruiting for a Quality Systems Quality Control Coordinator in Draper, Utah or a mutually agreed Johnson & Johnson location. Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives. The Quality Systems Quality Control Coordinator, as part of the Quality Systems role is responsible for supporting Change Control, Investigation, Corrective Actions and Preventative Actions (CAPA), Metrics, Training and Document Control. The Quality Control role is responsible for providing product and stability testing expertise, to include microbiology, chemistry, and stability for OOS/MPS investigations The Quality Systems Quality Control Coordinator will support the preparation, review, processing, approval and closure of change controls, and will assist change control owners in the research and writing of change controls. The Quality Systems Quality Control Coordinator will initiate and author internal JJCI Quality Systems investigations and CAPAs, as needed. This position will also be the primary Subject Matter Expert (SME) for the Training system as well as the Document Control Process (Tru). The Quality Systems Quality Control Coordinator will provide oversight of all change controls, investigations, and CAPA within the EtQ system. The Quality Systems Quality Control Coordinator will drive results and is responsible for the administration, effectiveness and continuous improvement to ensure the viability of these processes. The Quality Systems Quality Control Coordinator will also serve as a Super User for the EtQ and Qlik systems and is responsible for local system administration. The Quality Systems Quality Control Coordinator will participate as a team member on both internal and external project teams interfacing primarily with Technical, Quality Assurance, Internal Operations and R&D groups, and supporting EMs with test result OOS or investigations related to microbiology, chemistry, stability issues. This role will also maintain the audit playbook and establish an audit readiness program to support the auditing process to include internal, JJRC and Regulatory audits. . This position will collect and monitor weekly, monthly, quarterly metrics as well as identifying trends, opportunities, and overall adherence to the Metric monitoring processes. Key Responsibilities Act as SME for Investigations, CAPA and Change Control systems Act as SME for metrics, training and document control Act as SME for laboratory and stability test results, as needed Review change controls, investigations, CAPAs for adherence to procedures Act as audit lead for internal, JJRC, and Regulatory Body audits Act as local ETQ Super User and Local Administrator Act as local Tru user Act as local ComplianceWire/Summit admin Report Investigation, CAPA and Change Control metrics Report training, document control metrics Develop robust metric reporting process Special projects as required The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all the responsibilities, duties & skills required of personnel so classified. Qualifications A minimum of a Bachelor's Degree (BA/BS) is required. A focused degree in Chemistry, Microbiology, Biology, or Biological Sciences or Information Management is preferred. A minimum of 4 Years Work Experience is required A minimum of 5 years (or an Advanced degree/MBA in related discipline and a minimum of 4 years) of GMP Quality and Compliance experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Industry is required. Detailed working knowledge of cGMP requirements and current FDA enforcement issues is required. Laboratory experience to include Microbiology, Analytical, and Stability testing is desirable. Experience in MS Word, Excel, and Power Point applications is required. Strong experience in EtQ, Qlik, TRU, Compliance Wire, and Summit is required. Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with senior levels of management to inform, drive change, and provide direct feedback is required. Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction is required. Proven ability to lead and influence others within product teams with excellent communication and presentation skills Experience working remotely with business partners in a global environment is preferred Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority required Detail-oriented, with the ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability required Up to 10% domestic and international travel is required. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Utah-Draper-Zarbee's Organization Zarbees (6263) Job Function Quality Requisition ID 2105933444W

Keywords: Johnson & Johnson, Draper , Quality Systems and Quality Control Coordinator, Other , Draper, Utah

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