GMP Manufacturing Coordinator

 

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 cGMP Manufacturing Coordinator position is a key role within our GMP Operations Systems & Support team, which also includes Facility Support, Manufacturing Compliance, Manufacturing Training, and our GMP Packaging team.   Expectations of the GMP Operations System & Support team is to ensure “Compliance” and “Readiness” within our GMP Manufacturing teams, ultimately enabling high manufacturing success.  Job duties include:

  

• Assist the manufacturing teams with production readiness, inventory maintenance, material movements, sample coordination, and batch planning
• Interact cross-functionally with Manufacturing, Project Management, Technical Operations, Procurement, Quality Control, Quality Assurance, Packaging, Materials Management, and Distribution, with communication responsibilities from batch manufacture through packaging and distribution activities
• Assess material needs against approved BOMs and coordinate with procurement to ensure manufacturing readiness in accordance with manufacturing schedules
• Track received materials through release and transfer into the production facilities. Upon physical consumption into the manufacturing process, consume and return to inventory all materials
• Utilize ERP system for material movements, consumptions, etc.
• Input Manufacturing hours and manage Process Orders and Process Order Variances
• Adhere to ICH Q7 quality regulations
• Assist in batch planning with operations management
• Perform cycle counts on production inventory
• Process inventory discard reports and process inventory accordingly
• Attend and represent production needs at raw material readiness meetings
• Operate within OSHA guidelines for safe working environments
• Operate within EPA guidelines

 

Who You Are:

 

Minimum Qualifications:

• Bachelor’s Degree in any discipline
• 2 + years of experience working with an ERP system, such as SAP
• 2 + years of experience in a cGMP setting in manufacturing, manufacturing planning or inventory analyst

                           OR

• High School Diploma or GED
• 6 + years of experience in a cGMP setting in manufacturing, manufacturing planning or inventory analyst
• 4+ years of experience working with an ERP system, such as SAP

 

Preferred Qualifications:

• Bachelor’s Degree in a Life Science discipline (e.g. Chemistry, Biology, etc.) or Operations/Business Management
• Experience in ICH Q7 regulations
• 5+ years in a cGMP setting
• Experience maintaining and coordinating multiple projects across multiple departments
• Knowledge of Six Sigma concepts/Lean Manufacturing and process improvement
• Strong oral and written communication
• Experience in SAP logistics module
• Highly proficient with Microsoft Office for manufacturing, operating procedure writing, technical report generation, product tracking and trending data analysis

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