Senior Quality Assurance Specialist (Hybrid)

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

The Senior Quality Assurance Specialist is a systems and product support role that will initiate and manage the implementation and maintenance of quality systems supporting operations, quality, and product compliance. This may include support and management of the Deviation and CAPA Program, Complaint and Customer Notification Program, Internal audit Program, Change Control Management, Document and Record Control, Training Program and product support functions supported by the Quality Systems. The Senior Quality Assurance Specialist is a highly motivated and meticulous individual with excellent problem-solving and communication skills. The Senior Quality Assurance Specialist responsibilities focus on enhancing manufacturing site by providing expertise in advanced problem solving and implementation of corrective and preventative actions. The Senior Quality Assurance Specialist works closely with internal team members, stakeholders, collaborators, and participating facilities to ensure that root cause analysis is conducted in a timely manner to achieve goals. Additional responsibilities include:

• Provides Root Cause Analysis (RCA) support using performance improvement tools (e.g.,5 Why, Is/Is not, fishbone) and methodology, in addition to project management support for systemwide root cause analysis.
• 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 management etc.) 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 and applies and interprets regulations in making business decisions and risk assessments. 
• Establishes and maintains collaborative relationships 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, R&D, Production, and other support groups requesting additional information for regulated products, product status, or quality support. 
• Lead change 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.
• Support product initiatives or custom business opportunities.
• Lead Administrative user for TrackWise Quality Management System Software.
• Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values.
• Act as Lead Auditor of Internal Auditing Teams
• Conduct Training (individual, group, departmental & the entire Quality System)
• Participation in customer audits, regulatory audits, registration audits as a Subject Matter Expert of applicable Quality Management Systems

Who you are:

Minimum Qualifications:

• Bachelor’s degree in Life Sciences discipline, (Chemistry, Pharmacy, Chemical or Process Engineering) along with 4+ years of experience in Quality System (i.e., ISO environment) with experience in a specific QA job function

or

• Bachelor’s degree in any discipline along with 10+ years of Quality System (i.e., ISO environment) with experience in a specific QA job function

or 

• Master’s degree or PhD Degree in Chemistry, Biochemistry, Biol