Job Description

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.

Your Role:

The primary responsibilities of the Specialist, Quality Assurance, is product quality and manufacturing oversight including, on the floor support and guiding change controls, deviations, investigations, RCA\'s, and ensuring compliance with regulatory expectations. The Specialist, Quality Assurance, functions as a key technical resource in the Quality Operations organization and is technical expert on assigned product and related manufacturing operations. Role responsibilities will include:

• Supporting management during regulatory inspections, e.g., providing details and rationale of change controls, deviations, investigations.
• Provide direct quality oversight for manufacturing, real-time consultation for changes/deviations, room inspections/releases, real-time batch record review, on the floor coaching and mentoring in cGMPs.
• Provide Quality Assurance expertise regarding product quality issues to ensure regulations and company standards are met (CFR, FDA and ICH, international cGMPs). Advice provided cross-functionally, to Supplier Quality and customers.
• Provide Quality Assurance leadership to others on appropriate use and implementation of Quality Assurance aspects of design control and commercialization process. Participate as member of various cross functional teams, as assigned to ensure QA principles are applied/ Quality System compliance is achieved. Develop strategy and lead implementation of quality and process control plans on product teams.
• Provide Quality input / guidance regarding development of manufacturing controls, specifications, and regulatory requirements for new products and/or manufacturing processes.
• Continually improve Quality System by investigating, developing, and implementing permanent corrective and preventive actions for process/system failures. Assemble individuals required for preparing / completing timely and thorough investigations, and actively participating in preparing investigations. Collaborate, in a hands-on manner, and provide direction on investigations and technical issues at the Indianapolis facility and at contract manufacturing sites.
• Investigate, develop, review and/or propose disposition of non-conforming materials; review and approve of product and process change requests, provide investigations, and change controls to client facing QA colleagues.
• Analyze, understand, and present technical data both internally and externally to customers/inspectors/auditors

Physical Aspects:

• Work in clean room environment

Who you are:

Minimum Qualifications:

• High School Diploma or GED and 5+ years of cGMP pharmaceutical manufacturing experience, FDA or other highly regulated environment experience OR Bachelor\'s Degree in Chemistry, Biology, Engineering or other Life Science field and 1+ years of cGMP pharmaceutical manufacturing experience, FDA, or other highly regulated environment experience

Preferred Qualifications:

• Understanding of technical basis of products and processes and the relationship to product performance. Experience with sterile drug products and biopharmaceuticals
• 1+ years\' experience with FDA and EU GMPs, and ICH Guidance

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