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
Overall responsibility for batch release for the customer includes all associated supporting documentation ensuring batches are release on time and in full
Immediate notification, management, and approval of customer product-specific deviations within the agreed timelines. Working with a cross-functional internal team to ensure investigations are conducted appropriately to meet customer expectation and timelines.
Collaboration with customers on product/project-specific CAPAs and overall responsibility to ensure CAPAs are effective and closed on time
Generation and management of customer-specific quality KPIs
Working with customers and operations to initiate change on behalf of the customer and ensure successful execution of the change
Conducting risk assessments for quality events and gaps between customer expectations and site capability
Representing the customer within operations with quality oversight in manufacturing and attendance at Daily Management System (DMS) meetings
Point person for customers' Person in Plant (PIP)
Participating in and helping prepare for customer or regulatory audits and assessments within the MilliporeSigma organization in collaboration with the audit team
Point person for customer-specific regulatory audits in collaboration with the audit team.
Preparation for, attendance, and presenting at all customer quality-related meetings.
Provide leadership skills as a quality project lead
Who You Are
Minimum Qualifications:
Bachelor's Degree in Chemistry, Chemical Engineering, Biology or other Life Science discipline
3+ years of experience in a cGMP pharmaceutical environment
Preferred Qualifications:
4+ years of cGMP pharmaceutical quality assurance experience
Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing - FDA regulations (21 CFR Parts 11, 210, 211 etc.) and ICH Q7 Good Manufacturing Guidance for APIs
Detailed knowledge of quality assurance, cGMP and/or other relevant quality systems with strong evidence of collaborating in a matrix environment
Proficient knowledge of Microsoft Office, Word, Excel
Excellent communication skills, both written and verbal - high level of professionalism required for a client-facing position
Excellent organizational and project management skills
Detail-oriented and results-driven
Team player -collaborate across cross-functional teams and departments
Prioritization and time management skills -juggle multiple projects and tasks
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
