Quality Assurance Specialist at EMD Millipore Corporation

St. Louis, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

42.98

Posted On

06 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, ISO Compliance, Regulatory Compliance, Auditing, Documentation Control, Training, Problem Solving, Time Management, Communication, Customer Service, Technical Writing, Continuous Improvement, CAPA Management, Data Analysis, Team Collaboration, Process Improvement

Industry

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 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 both ISO and non-GMP production environments, ensuring compliance with Life Science and site quality policies. Drive quality improvement across multiple departments by completing a high volume of work to meet department goals. Communicate effectively with coworkers, other departments, and management, bringing critical deviations and operational statuses to their attention. Perform internal and external audits, representing the site during customer and regulatory inspections. Contribute to investigations of customer complaints, nonconforming incidents, and effectiveness checks. Assist in maintaining department KPIs by ensuring the timely completion of CAPAs, Deviations, Complaints, and Change Controls. Manage documentation control activities, including the electronic documentation system, and write, review, or approve various controlled documents like SOPs and master manufacturing procedures. Conduct quality system training for staff to ensure adherence to quality guidelines and accurate work. Who You Are Minimum Qualifications: Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) 3+ years’ experience in a QA job function. OR Bachelor’s Degree in any discipline. 5+ years Quality System (i.e., ISO environment) experience in the QA job function. Preferred Qualifications: Master degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering. Knowledge 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. Current fine chemical industry knowledge &/or experience. 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. RSREMD Pay Range for this position: $28.65-$42.98 per hour. 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. For more information click here. 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! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

The Quality Assurance Specialist provides compliance oversight across the Quality Management System and is responsible for the implementation and maintenance of Quality Systems and processes. Responsibilities include driving quality improvement, performing audits, and managing documentation control activities.