Data Analyst-00000T29
Description
Janssen Supply Group, LLC is recruiting for a Data Analyst to be based in one of the following locations: Raritan, NJ; Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Gurabo, PR; Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; or Schaffhausen, Switzerland – with Horsham, PA being the preferred location.
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Data Analyst conducts trend analysis on quality metrics (i.e. events, non-conformance (NC), CAPA, training, etc) data and develops techniques to identify insights, risks and early warning signs of negative trends. The Data Analyst coordinates with metric owners and organizations, gathering commentary to complete the picture on CAPA and NC performance during regular management reviews. Works closely with manufacturing sites to highlight trends and or re-occurring themes in NCs and CAPAs to ensure they get embedded into improvement plans and with Quality Assurance to set annual targets and improvement goals. This position is accountable for supporting business relationships within or across all relevant functional areas.
The Data Analyst provides support to the Supply Chain NC and CAPA metrics reporting process across the Janssen Supply Chain. Provides timely and accurate reporting of NC and CAPA performance, and manages Quality System investigation, non-conformance and CAPA analytics and reporting. Primary responsibility is to produce accurate, timely and complete, standard performance and trend reports for management review, which impacts and aids in determining management action, resource allocation and investment in continuous improvement activity. The role applies knowledge and understanding of CAPA and NC system regulations and standards, including but not limited to ISO 13485, FDA 21 CFR Parts 3, 4 210, 211 and 820, in order to identify, trend, and communicate analytical and data trends and outcomes.
Additional responsibilities will include: Producing ad hoc reports at the request of management. Must possess significant expertise in software, including Excel, PowerPoint, Visio and SharePoint. Identifying continuous improvement efforts in reporting efficiency and accuracy through rationalization and improvement in the various systems capturing NC and CAPA data. Conducting queries and mining large data sets to identify patterns; examining data and filter for targeted information using predictive analytic methodologies. Modeling data to build innovative solutions to solve complex analytical problems. Working with business partners to design and develop analysis modules, data quality controls, user interfaces and reports. Developing methodologies that allow for efficient and repetitive data extraction processes. Prioritizing and managing multiple complex simultaneous tasks and projects. Providing ad-hoc support to key areas, as well as well-written documentation to help drive successful implementation of solutions. Developing, implementing and utilizing data analytics protocols, standards and tools necessary for audits, testing engagements and data analysis monitoring assignments. Sourcing internal data and data validation, and managing specialized queries and reporting. Collaborating closely with key business partners to identify and implement additional manufacturing metrics to be tracked. Presenting metrics and analytics to all levels of employees, including senior management in a clear concise manner. Assisting manufacturing and reliability team members in implementation, maintenance, and data mining for special projects and continuous improvement efforts. Key functions that the Analyst will interact with include Site Quality, Enterprise Quality Systems, Compliance, Business Quality, External Manufacturing QA, Product Deployment, Procurement, Manufacturing and Regulatory Affairs. Responding to inquiries from all levels of employees or external sources regarding a variety of questions. Maintaining strict confidentiality, with the ability to exercise sound judgment and discretion. Possessing the flexibility to respond to shifting priorities with great frequency.
Qualifications
A minimum of a Bachelor’s Degree in Science, Business, Engineering, Operations Management or related field is required. A minimum of 3 years of related experience is required. Knowledge of MS Excel, data management and basic statistics is required. A working knowledge of relevant sections of US CFR parts 210, 211 and/or 820 related to non-conformance and CAPA is preferred. Knowledge and experience in project management and program management processes and tools is preferred. Experience with Six Sigma/Process Excellence tools, training and/or certification is preferred.
The ability to multi-task, work with minimal supervision, and demonstrate resiliency and high productivity in a fast-paced environment is required, operating with a high sense of urgency while maintaining a high degree of professionalism. Experience supporting and working in a matrix organization is preferred. Must have the ability to communicate across all levels of the organization. Strong organizational, conflict management and decision-making skills are required. Must be able to manage multiple priorities, maintain confidentiality and operate with poise and professionalism in a complex, high-profile and rapidly changing environment.
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Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-Puerto Rico-Gurabo, Europe/Middle East/Africa-Ireland-Cork-Cork, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Control
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