MilliporeSigma Sr. Quality Assurance Specialist - 743520901 in Topeka, Kansas
This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/11739901 A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Senior Quality Assurance Specialist in Lenexa is a systems and product support role that will initiate and manage the implementation and maintenance of quality systems supporting operations, product compliance statements, Deviation and CAPA program management, Complaint program management, and product support functions supported by the Quality Systems and Product Support Department. The Senior Quality Assurance Specialistis a highly motivated and meticulous individual with excellent problem-solving and communication skills. The Senior Quality Assurance Specialist is the first point of contact for management of internal and external nonconformities. Responsibilities focus on enhancing the Lenexa Dry Powder Media manufacturing siteby providing expertise in advanced problem solvingand implementation of corrective and preventative actions. The Senior Quality Assurance Specialist works closely with internal team members (on the shop floor), stakeholders, collaborators, and participating facilities to ensure that root cause analysis are conducted in a timely manner to achieve goals.
+ Provides Root Cause Analysis (RCA) support using performance improvement tools (e.g. process maps, 5 Why, Is/Is not, fishbone) and methodology, in addition to project management support for system-wide root cause analysis for the Lenexa, KS and Sinking Spring, PA Dry Powder facilities.
+ Serves as an operational resource in the analysis of risk for adverse events through the root cause analysis process.
+ Drives expedited problem identification and resolution, provision of RCA-specific updates, and team interactions and deadlines driven by product release.
+ Utilizes project management tools and methodologies to track and communicate the status of RCA and provides regular updates to the RCA Teams, ensuring the team is informed of status updates of the root cause analysis.
+ Develops appropriate communication plans and strategies to ensure information is openly communicated.
+ Demonstrates leadership in developing and implementing quality system initiatives in areas of Operations and Product Support.
+ Recognize those areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Training, Nonconformance managementetc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems to ensure a level at or above industry standards.
+ Support the Development of project plans for specific quality system initiatives and process improvements.
+ Maintains current understanding of quality systems for business units including DPM (Dry Powder Media products)and applies and interprets regulations in making business decisions and risk assessments.
+ Establishes and maintains collaborative relations hips within the system in order to obtain information and content from leaders and front-line staff to foster successful root cause analysis completion.
+ Act as initial contact with Product Engineering requesting additional information for regulated products, product status, or quality support.
+ Leadchange team assessment of end-to-end impact for product, process, systems, assay/method, and equipment change controls
+ Develops and manages best practices and tools for improvement, plan execution, and project management.
+ Provide cost and lead-time information for custom documentation requests or answer quality policy and compliance questions for Sales, Sales support staff, Technical Managers, and other business unit support functions.
+ Support product initiatives or custom business opportunities.
+ Lead Administrative user for TrackWise QualityManagement System Software.
+ Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values.
Who You Are
+ + Bachelor's Degree in Chemistry, Biology, or related Life Science discipline OR healthcare-related field
+ 2+ years of experience in a quality assurance or quality control position
+ 2+ years of experience leading or participating in Root Cause