US-MA, Sr QA Specialist I SR0029874-MZ
This individual is responsible for providing senior level support for issues of moderate complexity at a minimum, with the Raw Materials Value Stream. This area supports release of chemical raw materials, components, packaging and processing aids. In addition, this area is responsible for oversight and disposition of Cell Banks. Routine management & coordination of GMP compliance systems (Quality Systems Deviation, CAPA, Change Control) and policies for cGMP compliant facilities for disposition of raw materials & components. Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Examines programs to create efficiencies in practices. Assures cGMP s and company procedures are followed and, if needed, procedures/policies are revised. Accountable for meeting functional area goals and objectives as they relate to departmental and Takeda goals. Responsible for adhering to GMP regulations, cGMP s, company policies, and leadership capabilities. Responsibilities % of Time Job Function and Description 30% Quality Systems 30% New Product Introduction Support / Specifications 20% Document (Procedure / Protocol / Report) Review 20% Continuous Improvement Support of customer group quality systems Develop and aid in development of solutions for moderate to complex problems Work on moderate to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results Network with key contacts outside own area of expertise Contribute to the development of new concepts, techniques, and standards Work independently without appreciable direction Exercise latitude in determining objectives and approaches to assignments Serve as special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives Ensuring that practices are consistent with quality and regulatory standards Providing support during regulatory agency site inspections Support an environment of teamwork and collaboration Project and improvement initiative participation Education & Experience Requirements Essential: A minimum of a B.S. degree in science or engineering with at least 5-10 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis. Excellent interpersonal skills and the ability to communicate well orally and in writing. Desired: Direct Biologic Pharmaceuticals experience within Technical Operations Key Skills, Abilities & Competencies Able to perform functions in accordance with cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe. Ability to create, manage and improve complex Quality systems, integrating with existing systems Ability to work effectively in a fast-paced environment Strong written and oral communication skills required Good interpersonal skills required Adherence to domestic and international GMP regulations, cGMP s, company policies and company leadership expectations. Teamwork skills essential Strong organizational skills Ability to multi-task in a dynamic environment with changing priorities Strong work ethic Ability to meet challenging timelines, in spite of obstacles. Flexible Strong prioritization and delegation skills Ability to think strategically and tactically, balancing these as workload changes Self-motivated and driven to independently accomplish department goals and objectives Positive outlook and motivating, in spite of obstacles Understands the needs of key collaborators and customers, and interacts effectively intra- and interdepartmentally to achieve alignment and consensus. Must be capable of defining, implementing, and successfully defending sound QA systems approaches and principles. Demonstrate unwavering ethics and respect for all customers. Practice open and honest communication, building authentic relations. The individual must be flexible to effectively embrace change. When faced with challenging circumstances, finds creative ways to ensure achievement of the desired, compliant outcome. Plans, organizes and communicates with others who may have concurrent work streams. Proactively improves customer service. Demonstrate genuine respect for others. Seeks greater understanding of self and others: Seeks feedback about one s own behavior Demonstrates leadership qualities. Works effectively in situations that are outside one s usual activities and responsibilities. Seeks the input of others before making a decision as needed Demonstrates personal dedication; balances personal needs with Takeda s needs. Illustrates dedication to Takeda by going above and beyond expected individual responsibilities. Complexity and Problem Solving Employee at this level is involved in a variety of tasks of high level / wide scope and complexity. This individual will be the primary quality assurance representative on multiple Working Teams and is empowered to make strategic Quality Assurance decisions including troubleshooting issues related to quality concerns, implementing effective solutions and corrective actions. It is incumbent upon this individual to bring any concerns to direct manager or areas of significant cross- functional disagreement to manager. Candidate must be able to perform functions under least supervision. Receives general instructions on new work; refers to policies and practices for guidance. Work is reviewed for technical soundness and accuracy. Internal & External Contacts Contacts are primarily with other professionals in the group (Quality) and QA Operations, Quality Control Raw Materials, Materials Management, Procurement, Manufacturing, Facilities / Engineering, Regulatory, Quality Control, Operational Excellence, and Project Management. Other Job Requirements Must be flexible to work late shifts and weekends on ad-hoc basis, primarily during regulatory agency inspections, priority assignments, and product launch activities. Key Leadership Capabilities / Behaviors: Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others
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