About this role
<p style="text-align:justify"> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Your Magic with us! <span style="color:#ffffff">Start your next chapter and join MilliporeSigma.</span></span></span></p> <p> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">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. </span></span></p> <p> </p> <p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. </span></span></p> <p> </p><p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Your Role:</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">At MilliporeSigma, as a Quality Assurance Specialist 3, your tasks will include conducting audits and review/approval of various types of regulated documentation.</span></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Review and approve RCA analysis for robustness and accuracy and/or perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Train and/or provide peer mentorship in the root cause Investigative Process and techniques.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Analyze and evaluate information captured through investigations, communicate findings and recommendations Review and approve OOS, trend, critical-impact deviations and lower impact deviations and conduct trend analysis for deviations.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Review / approve applicable CAPA records and conduct Effectiveness checks.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Review and approve change control (GCC) records.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Train Quality Specialists and/or Operations teams on quality topics. </span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Provide support for regulatory inspections and for client regulatory submissions.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Act as Quality SME during regulatory inspections and customer audits for areas of expertise.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Conduct laboratory inspections to include internal audits and assay methods.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Author, review and approve standard operating procedures (SOPs), quality policy documents.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">May review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">May review and approve validation files for systems and assays.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">May perform risk assessment using various methodologies.</span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Who You Are</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Minimum Qualifications:</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">1+ years' experience in conducting and/or reviewing root cause analysis and CAPA for deviations and out-of-specification (OOS) results in a Quality Assurance role </span></li> </ul> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Verdana, sans-serif">Preferred Qualifications:</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Excellent communication and interpersonal skills.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Ensures quality of own work in an ethical manner.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Open-minded, flexible and works with agility.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Meets assigned deadlines.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Works with cross-functional teams and builds networks within QA and Operations departments.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Collaborates with various teams to identify and implement improvements.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Verdana, sans-serif">Willing to embrace and implement change on a global scale.</span></li> </ul> <p style="margin:0.0in 0.0in 8.0pt 0.25in;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"> </p> <p style="margin:0.0in 0.0in 8.0pt 0.25in;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:12.0pt">Pay Range for this position - $70,800 - $106,200</span></p> <p style="margin:0.0in 0.0in 8.0pt 0.25in;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-family:verdana, geneva, sans-serif;font-size:12.0pt">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 <a href="https://careers.emdgroup.com/us/en/benefits" target="_blank" rel="noopener"><strong>here</strong></a>.</span></p><p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>What we offer:</strong> 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!</span></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!</span></span></p>