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:

This position is responsible for leading the Quality Document Control and Product Release teams within a complex parenteral manufacturing facility and providing functional leadership of Batch Record Review and Product Release, Batch Record Issuance, Document Control/Archival and related investigations/CAPAs. The individual champions continuous improvement activities with quantitative results that consistently deliver low cost, defect free products on-time. The position is a working supervisory position that supports production and related activities to product release. The position collaborates with other QA personnel, Quality Control, Operations, Clients, and Suppliers to establish and maintain requirements for product release and document management. Responsible for ensuring that all product manufactured and/or supported meet established specifications and regulatory requirements.

 

Responsibilities include but are not limited to:

Oversees/performs activities for QA product release and issuance and management of GMP documentation. Provides direct QA oversight over product release and issuance teams. Ensures all duties are performed in accordance with cGMP.Oversight of the issuance, release, and archival of GMP documentation for execution by Manufacturing personnel and other functional departments.Ensure batch records are reviewed by Quality in a timely fashion, with established targets and visibility to stakeholders.Supervises and performs the activities of the department including customarily and regularly directing, advising, and managing direct reports.Assesses departmental productivity and efficiency to provide on time delivery of services by the department. Participates in the appropriate selection and usage of resources (materials, systems and/or equipment) required for the effective operation of the department.Provides for team member safety by promoting safe work practices, monitoring compliance with EHS policies, and minimizing physical hazards to promote an overall safe work environment.Monitors Quality Assurance programs to ensure process controls are met, documents activities, and brings about corrective action.Assists in audits, documents audit results, and provides input and recommendations for necessary corrective action as needed.Ensure adherence to the manufacturing schedule through effective planning and on-time issuance of GMP documentation.Schedule and track conformance to batch release schedules, establish milestones and escalation processes. Manage and/or support process-related investigations. Train and qualify individuals on batch disposition and issuance and document management activities. Participate in the oversight and governance of the overall site quality systems, partner with quality colleagues to ensure communications between operations quality and product support quality personnel are effective.

 

Who You Are:

 

Minimum Qualifications:

Bachelors Degree in Biology, Chemistry, or other Life Science Discipline.  3+ years of quality assurance experience.

Preferred Qualifications:

Experience within a cGMP regulated environment.  Experience with continuous improvement efforts.Experience in client interactions.Strong oral and written communication skills.Strong ability to train others in activities related to pharmaceutical manufacturing quality.Self-motivated, resilient, team-oriented, and a results-oriented person.

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