Quality Assurance Specialist 2

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

As the Quality Assurance Specialist 2 at MilliporeSigma in Norwood, OH, you are a key contributing team member of the Quality Assurance team behind the site’s alignment to the ISO 9001:2015 Quality Management System (QMS) standard. Your role requires attention to detail, thoroughness, and communication skills as you administer the electronic Quality Records system on the site to ensure that records are entered, processed, and completed in a timely manner (within defined due dates). Daily tasks include the following:

• Owns the customer complaint process and working with customers, Product Managers, Account Managers, Technical Services, and Customer Services to investigate and process complaints in a timely and thorough manner.
• Acts as the Site Lead User for all modules of the TrackWise electronic quality record system (Complaint, Change Control, Audit, CAPA, Deviation, RCA). 
• Ensures records in all modules are entered, processed, and completed in a timely manner and within due dates.
• Coordinates external audits and assists the QA Supervisor in conducting Internal QMS audits, as well as other activities as needed/defined by the QA Supervisor and/or the Quality Manager.
• Maintains and analyzes complaint-related metrics and holds monthly complaint meetings.
• Ensures critical investigations are completed successfully and according to established protocols; leads or assists in conducting in-depth analyses of out-of-specification (OOS), Corrective and Preventive Action (CAPA), Complaint, Deviation, Change Controls, and Root Cause Analysis (RCA).
• Provides QA support for Distribution quality issues and initiatives.
• Works with the QA team to write, review, and approve Operating Procedures, Work Instructions, and Forms for the QA group.
• Monitors the production floor, QC labs, and DC warehouses for any quality-related issues, taking prompt action and collaborating closely with stakeholders to swiftly resolve issues.
• Leads or assists (as applicable) process improvement initiatives and projects, leveraging your expertise to drive continuous improvement of quality-related practices, methods, and systems.
• Monitors LS monthly metrics (Heatmap, QIP’s, Global Documents, IMR and Supplier reviews).

Who you are:

Minimum Qualifications:

• Bachelor’s Degree in a Life Sciences (e.g., Chemistry, Pharmacy, etc.) or Engineering (e.g. Chemical Engineering, Mechanical Engineering, etc.) discipline.
• 3+ years of work experience in a QA function.

Preferred Qualifications:

• ISO 9001 Lead Auditor.
• 2+ years of customer facing experience.
• TrackWise and SAP experience.
• Complaint processing experience.
• Experience communicating across all levels of an organization.
• Report writing skills.
• Knowledge of GDP/GMP methods and processes. 
• Ability to multiple projects/tasks/priorities simultaneously.
• Excellent problem-solving skills.
• Knowledge of data analysis, presentation, and experimental design.
• Excellent computer skills.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html