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Quality Specialist 3 - System Audits
Work Your Magic with us!
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.
The Quality Specialist 3 performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation. Impacts the results of the Quality Assurance (QA) team and influences a range of customer, operational, project activities of Operations teams. Solves problems of varying complexity independently by identifying and selecting solutions and by analyzing information. May also support management in facilitating work assignments and training plans for system audits team.
Essential Job Functions:
- Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
- Review and approve validation documents against regulatory and internal requirements as to include, as applicable, requirements, risk assessments, protocols, testing, final/summary reports, trace matrix, etc.
- Review and approve deviations / OOS records of varying impact and criticality
- Conduct trend analysis for deviations and review / approve applicable CAPA records
- Conduct laboratory inspections to include commissioning and/or internal audits
- Provide support for client regulatory submissions, client audits and supplier audits with regards to validation activities
- Review and approve change control (GCC) records
- Represent quality in meetings with external parties, where appropriate
- Provide support for regulatory inspections
- Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics
Who You Are:
- Bachelor’s Degree in a scientific field (e.g., Chemistry, Biology, etc.) or technical field (e.g., Chemical Engineering, etc.)
- 3+ years' experience in Quality Assurance or quality experience within a GxP environment
- GAMP knowledge
- Acts ethically and ensures quality of own work and that of others
- Open-minded, flexible and works with agility
- Takes responsibility for ensuring that turnaround times are met
- Works with cross-functional teams and builds networks within QA and Operations departments
- Collaborates with various teams to identify and implement improvements
- Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
- Excellent communication and interpersonal 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