US-CA, Senior Quality Assurance Specialist SR0023782-MZ
Summary Responsible for the managing the day-to-day Quality operations for Formulation and Filling (FF) Manufacturing. Identify and assess quality risk in activities and processes according to guidelines and Takeda standard operating procedures. Proficient in facility Quality Systems particularly Change Control and Exception Management/CAPA. Knowledgeable of FF Manufacturing Processes in order to support day to day activities including troubleshooting, problem solving, decision making, and resolution execution. Proactively participates in processes and serves as a driver for general process/system improvements. Essential Duties & Responsibilities Responsible for review of quality related documentation and approval of events and change control including assessing the risk and impact to the process and/or product as applicable. Assess impact of new regulations on current practices, initiate document change proposals, prepare/review/approve protocols to justify process changes, approve validation protocols, and assist with training and auditing as appropriate. Lead ongoing daily departmental activities for areas of direct responsibility and when required assist other Quality areas in the successful performance of these activities. Responsible for overseeing the closure of nonconformance reports pertaining to areas of responsibility. Able to apply problem solving tools and methods to coordinate and/or lead investigation teams. Lead investigations (i.e. CAPA) for process failures within respective areas. Serve as QA representative as a core team member for projects, participate and own project milestones and implementation actions. Responsible for trending and analyzing data, and presentation of Quality System indicators to all organizational levels. Services as a subject matter expert in internal, corporate and external audits for areas of expertise. Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability. Acts as a change-agent and drives continuous improvement activities within the QA organization and across the facility as assigned. Assume a leadership role in absence of the Quality Manager. May perform other duties as assigned. May perform other duties as assigned. Qualifications Proficient in problem solving through the use of continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent Strong verbal, written and oral communication skills. Able to present business indicators to senior management Demonstrates proficiency in multiple quality systems including exception management, change control, document control, product release, supplier quality, etc. with strong decision-making skills utilizing risk management Lead multiple tasks/projects within timelines Demonstrates leadership by identifying improvement opportunities and implementing solutions General knowledge of cGMP (US, EU, Canadian, Japan) required General knowledge of manufacturing processes, laboratory operations and/or critical systems required Able to present areas of responsibility to regulatory agencies during inspections Able to assume responsibilities of Manager Able to supervise employees, conduct performance reviews, establish development plans and manage resources. Passion for Improving Lives. Must be able to put our patients at the center of everything we do. Quest for Innovation. Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations. Inspired Teams environment. Must be able to thrive in diverse high performing teams. Engaged with the World Around Us. Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world. Education and/or Experience Bachelor's degree in Sciences or Engineering and 5-8 years experience in quality operations within a biotechnology, biologics, or pharmaceutical manufacturing facility. Previous supervisory experience preferred. Working Environment Normal office environment. May be required to travel for business reasons, e.g. training and meetings. Will have interaction with other people. Pace may be fast and job completion demands may be high. Must be able to work in controlled clean room environment requiring special gowning. Requirements include: no jewelry or cosmetics. Special gowning requires complete coverage of head, face, hands, feet and body. Personal protective equipment must be worn due to safety requirements. Physical Demand Gowning in controlled areas Frequently - May require periodic standing in manufacturing areas. Drive - Rarely - as to non-commercial motor vehicles. Communication - Constant - Employees must be able to communicate orally and in writing in a clear, concise undersandable manner to supervisor and instruct co-employees. Including use of computer, telephone and related communication instruments Definitions: Rarely: 1-5 percent of the time in a ten hour day Occasionally: 6-32 percent of the time in an ten hour day Frequently: 33-66 percent of the time in an ten hour day Constant: 67-100 percent of the time in an ten hour day
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