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 Quality Assurance Project Manager at Millipore Sigma in St. Louis, MO (Cherokee) supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7) and Drug Products. In this role, you will be overseeing projects/products status and serve as liaison between QA and customer/clients. The position is also accountable for the on-time delivery of QA actions to Clients. The position reports to the QA OPS Management team and typical work hours from 8 am to 5 pm. There are no direct reports for this role.
Lead QA in global client/customer meetings (various time zones)
Work closely with QA specialists, management, and client project managers (CPM) on all QA tasks related to the customer project and track on time deliveries (OTD)
Escalate delays, and potential risks to QA management.
Communicate to CPM and clients on QA status and any potential risks to products and or deliverables.
Compile and provide customer requested memos/documents.
Complete impact assessments for QA OPS related change controls.
Plan, schedule, and track QA releases and communicate schedule to the QA OPS batch release.
Act as a liaison between the site and the customer for all TrackWise and ManGo document approvals.
Design and implement QA OPS efficiency/operational excellence initiatives.
Provide customer support and communications for rapid and effective resolutions pertaining to QA and non-conforming issues to customer.
Additional duties as assigned by QA Management.
Who You Are
Minimum Qualifications:
Bachelor's Degree in Chemistry, Chemical Engineering, or other life science discipline.
5+ years of QA and/or QC experience working in a cGMP environment.
Preferred Qualifications:
Sound knowledge of Quality Management Systems to be able to represent quality assurance during customer calls with ability to communicate applicable information back to the quality assurance team members.
Proven ability to build and maintain effective stakeholder relationships, with exceptional communication and interpersonal skills.
Demonstrated expertise in creating high-quality deliverables, such as detailed reports and presentations, tailored to client needs.
Proficiency in driving change management initiatives and collaborating with cross-functional teams to achieve cohesive project execution.
Prior experience handling customers/clients.
Outstanding written and verbal communication and customer interface skills
Strong computer skills, including proficiency in Word, Excel, and PowerPoint
Quality assurance experience with API manufacturing and testing knowledge desired
Experience writing technical documentation and reports.
Familiar with scientific/regulatory principles
Experience with TrackWise and SAP.
GDP, Data integrity and ALOCA.
Familiar with GMPs, FDA, ICH and OSHA requirements.
Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
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