Manufacturing Compliance Specialist

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:

At MilliporeSigma, as the Manufacturing Compliance Specialist at the Cherokee site (3300 S. Second Ave), is focused on ensuring manufacturing and packaging operations are complying with internal procedures. This role completes root cause analysis investigations, change controls and identifies and implements corrective and preventative actions. Job duties include:

• 
  Shift: 5:30am – 2:00pm, Monday- Friday
• Coordinate documentation and tasks associated with equipment and facilities:
  • Change management
  • New Equipment additions
  • Preventative maintenance and Calibration
  • Deviations and CAPAs
• Work with Manufacturing, Process Development, Maintenance, Engineering, Validation and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved, and implemented as appropriate
• Track and report progress of quality events to management and department impacted
• Assist with equipment, facility and process investigations, troubleshooting including root cause analysis
• Assist with manufacturing risk assessments
• Maintenance of quality systems and cGMP compliance
  • Ability to understand regulatory requirements such as ISO 13485 and 21 CFR Part 820
  • Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
  • Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
  • Assist with customer and regulatory audits.
• Maintain and review logbooks and other documentation to ensure audit readiness
• Always follow safety procedures
• Ensure chemical are stored under safe conditions with compatible materials
• Don, doff, use, and clean personal protective equipment appropriately
• Be familiar with hazards common to assigned work and take action to correct unsafe situations
• Participate in required safety activities such as training sessions, meetings, and safety inspections
• Develop and assist in the implementation of process improvement ideas
• Train other team members on general tasks and safety practices and documentation
• Comply with the requirements of ISO 13485 and ISO 9001

Physical Attributes:

• Ability to lift/move up to 35bs
• Walk, reach above shoulders, stoop, kneel, twist, crouch, crawl, and/or stand and perform repetitive movements for extended periods of time
• Ability to navigate 3 flights of stairs multiple times throughout the workday

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or other Life Science field of study
• 2 years of experience supporting/working in an ISO or GMP environment

Preferred Requirements:

• 1 year of experience in quality supporting role/field
• Understanding of SAP and Track wise
• Experience with root cause analysis

RSREMD

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