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.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 5+ years of experience working in the Life Science industry.

OR

• Bachelor’s Degree in any discipline and 5+ years working in a Quality Assurance role.

OR

• Masters Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry.

PREFERRED QUALIFICATIONS:

• 2+ years of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, EXCiPACT, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment
• Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.).
• Excellent communication (verbal & written) and customer services skills.
• Good writing skills and experience writing technical documentation & reports.
• Ability to simultaneously manage multiple tasks/priorities.
• Good problem-solving skills/abilities.
• Good time management and negotiating skills.
• Capacity for independent work.

Physical Requirements:

• Environmental conditions: Varies depending on specific job responsibilities.
• 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
• Physical requirements: Give site tours of facilities including use of stairs

The Quality Assurance Specialist provides compliance oversight across the St. Louis ISCO MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.

• Improve and maintain quality systems in ISO production environments, ensuring compliance with Life Science and site quality policies.
• Manage the electronic documentation system, which includes writing, reviewing, and approving controlled documents such as Standard Operating Procedures (SOPs), Specifications, and Master Manufacturing & Packaging Procedures.
• Oversee training management, including metric reporting and managing the electronic training platform, to meet departmental goals.
• Assist and/or act as a Lead Auditor in conducting internal audits to ensure compliance with quality policies.
• Support the department’s key performance indicators (KPIs) by ensuring the timely completion of Corrective and Preventive Actions (CAPAs), Deviations, Complaints, and Change Controls.
• Assist in the investigation of customer complaints and contribute to Root Cause Investigations and Effectiveness Checks for nonconforming incidents.
• Regularly communicate with coworkers and interact with other departments to support overall quality objectives.
• Conduct specific Quality System Training relevant to various job functions.

Physical Requirements:

• Environmental conditions: Varies depending on specific job responsibilities.
• 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
• Physical requirements: Give site tours of facilities including use of stairs.