US-IL, Launch Team, Quality Representative - Remote position SR0030565-MZ
Job Summary Primary Role Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Takeda Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. Essential Functions Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. New Center Quality Assurance Oversight: Provide on-site support of New Center Quality needs Serve as a Subject Matter Expert (SME) by maintaining a high level expertise in current regulatory requirements. Provide training and coaching to local and other employees as relevant on quality related matters. Serve as a coach to Quality Rep and ensure proper quality strategy and processes implemented prior to center opening and in early stages of center opening. Works in collaboration with center manager and management team to prepare for internal auditors and external inspectors. Provide new center inspection support and review inspection summaries. Assists center management teams to ensure timely closure of audit observations. Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Regulatory Compliance: Stays current with all federal, state, local and company-specific rules, regulations, and practices. Ensures New Center Development compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Assesses and ensures compliance for new center licensure. Ensures that SOP s are current and that staff perform routine tasks according to SOP through direct observation. Continuous Improvement: Identifies potential SOP revisions as needed to support continuous improvement for New Center Development. Collaborates with cross functional work teams to identify quality improvement opportunities as they related to New Center Development. Education & Experience Requirements Essential: High School Diploma or equivalent required. Minimum of one year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred. Computer skills in word processing, excel, data analysis and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem solving skills. Other Job Components Desired: Bachelor s degree preferred. Key Skills and Competencies Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Leadership Behaviors Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others Complexity and Problem Solving Responsible for providing guidance and expertise to Center and Quality Management teams Refers to Associate Quality Assurance Director for guidance on complex, high-impact or urgent decisions (internal) Responsible to collaborate with cross-functional Launch Team members on decisions impacting New Center Development Internal and External Contacts Reports to Associate Quality Assurance Director (Internal) Consults and coordinates directly with the Center Management, Quality Management and Launch Team on quality concerns within a new plasma center. Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience. Other Requirements Ability to travel up to 95% of the time domestically Requires valid state-issued driver s license and ability to secure rental vehicle. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen)
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