Quality Assurance Project Specialist
ATR International - Columbus, OH
Apply NowJob Description
We are seeking a Quality Assurance Project Specialist for a very important client.The Design Assurance Project Leader will work with product development teams to assure the quality, safety and efficacy of our products from development through commercialization. The Project Leader needs to be team oriented, agile, innovative and able to anticipate and mitigate risks. The Project Leader delivers timely, fact based, decisions focused on assuring quality products. Creates and maintains data, documentation and systems to track, monitor, and support the supplier management program. Ensures integrity, accuracy, consistency and completeness of area of responsibility. Corresponds with suppliers regarding inquiries and completion of documentation required by company policies and procedures, such as quality agreements, expectations, etc. Uses discretion in escalating unusual product performance issues, collaborates with other functional areas to discuss and resolve. Participates in product improvement teams, strategic program development, risk assessments and other analytical teams responsible for the improvement of products and regulatory issues. This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to internal customers' questions and requests. ? Interfaces with several multi functional areas, such as Research and Development, Quality Assurance, Legal, and Purchasing to document, review, and resolve supplier performance issues. Creates supplier exception report rate documentation for global review with US and international manufacturing facilities. Maintains the global approved supplier listing, communicates discrepancies to manufacturing plants and management, and provides solutions to address gaps/discrepancies. Conducts Label information reviews and collaborates with the labeling group to assure accuracy of ingredient allergen information. Provides support to management for event planning, meeting scheduling/planning/preparation, report preparation, correspondence/communications, and tracking department projects and timelines. The successful candidate works with their functional group peers and managers to define Design Assurance related deliverables to ensure successful scale up to commercial scale manufacturing (successful FLTS process). Together with R&D, Technical Centers and Plant operations the incumbent assesses critical to quality attributes and ensures the manufacturability of new formulations and products.The Quality Assurance Project Specialist is responsible for producing the highest quality results while operating within the constraints of the business timelines and guidelines. Responsibilities also include developing positive relations with other individuals within as well as outside the department. In addition to the duties described, the incumbent completes all other projects as assigned by management as well as assures compliance to Nutritional Regulations and Good Manufacturing Practices. Requirement: The ideal candidate will possess the following qualifications:Five - seven years of customer support, business, or project planning experience preferred. A high degree of interpersonal relations skills. Excellent verbal and written communication skills. Able to work independently and/or function with minimal supervision. Must be able to work under pressure and stress common to office environments. Must be able to maintain a high degree of accuracy and analytical thinking. Must be able to deal effectively with problems and customers. Must have knowledge of applicable regulatory standards and requirements for infant formula and nutritional products. Must have Advanced knowledge of Microsoft Office Suite, Adobe Acrobat, Visio, Access, and Lotus. '? Facilitates product technical risk management activities through product development stages? Utilizes developed knowledge to assure design, evaluate risk and successful manufacture.? Monitors product, process and package quality performance and identifies quality related issues and trends. ? Works with multiple functions including Supply Chain, R&D, Operations, and Regulatory. ? Works on problems of moderate scope where analysis of situation or data requires review of defined factors? Design Assurance Quality representative on cross-functional projects assigned? Displays working knowledge of relationships between regulations, labeling, process, and product. ? Displays working knowledge of applicable product regulations and policies ? Applies applicable product regulations and policies to assigned work. ? Inputs to assigned work teams, project timeline, risk identification, and elevates as needed to reporting manager ? Assures that the design and testing for assigned Nutritional products are fully compliant with applicable regulations Exhibits technical competence in data analysis of situation or data requires review of defined factors
Created: 2024-09-07