Quality Assurance Specialist

Biopharma Careers; Sheboygan Falls (WI); On-site; USD 69,000 - 116,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in the United States is seeking a Quality Assurance Specialist to support the development, maintenance, and improvement of quality systems with a strong focus on supplier quality management.

You will lead audits, drive quality initiatives, and ensure compliance with FDA and ISO standards, collaborating with cross-functional teams to align with business goals and customer expectations.

Qualifications

• Bachelor’s degree in biology, chemistry, engineering or related life science field.
• 5+ years in quality roles or 3+ years in production/project management.
• Experience with FDA, ISO quality standards and regulatory requirements.
• Experience with supplier quality management and audits.

Responsibilities

• Develop and maintain quality systems aligned with business goals.
• Lead supplier quality activities including audits.
• Drive quality improvement initiatives and system enhancements.
• Ensure compliance with regulatory requirements and document control.

Skills

Quality management

Audits

Regulatory knowledge

Analytical thinking

Communication skills

Education

Bachelor's degree in biology, chemistry, engineering

High School Diploma + 3+ years quality experience

Tools

SAP

TrackWise

Document Control Systems

Microsoft Office

Job description

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 Specialist will facilitate and support the development, maintenance, and improvement of quality systems, to ensure their alignment with business goals, customer expectations, and requirements for global business unit best practices. This position will have a strong focus in Supplier Quality Management and general Quality Management System requirements and improvements.

In this role, responsibilities include, but are not limited to:

• Quality system development and maintenance activities
• Support supplier quality management activities and programs
• Lead and facilitate supplier development activities including audits
• Lead, facilitate and support various quality system initiatives

Who You Are:

Minimum Qualifications:

• Bachelor’s degree in biology, chemistry, mechanical engineering, chemical engineering or other life science discipline or engineering discipline
• OR
• High School Diploma or GED and 3+ years of experience in a quality role or 5+ years in a production, or project management role

Preferred Qualifications:

• 3+ years of knowledge and experience in Quality Management Systems,ISO Quality Standards, and other regulatory standards as appropriate. (FDA, VDA, DOT, IATA, DEA, etc.)
• 1+ year of knowledge and experience in 21CFR117
• Experience with hosting and performing internal and external audits
• Experience with understanding data analysis, presentation, and experimental design
• Experience understanding current processing requirements for food, drug, industrial, and biologic types of products
• Strong oral and written communication skills
• Life science, Chemical, Food Industry, or Healthcare industry experience
• Experience with SAP, TrackWise, Document Control Systems, and Microsoft Office
• Experience in preparing and reviewingdocumentation to ensure compliance with company or customer quality requirements

Pay Range for this position: $69,100 - $115,600/yr

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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!