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QC Senior Scientific Reviewer (Carlsbad, California, US, 92009-1609) @ SUSONITY

Carlsbad, California, US, 92009-1609OnsiteFull-time
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<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&apos;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><span style="font-family:verdana, geneva, sans-serif"><strong>Your Role:</strong></span></p> <p><span style="font-family:verdana, geneva, sans-serif">The Quality Control Scientific Reviewer provides independent, data-driven review and oversight across in-process, release, and stability testing. Role will include technical writing of methods, protocols, reports, and investigations. This role integrates data reviews and trend analysis, and document quality assurance to support manufacturing, qualification, and lifecycle management of methods, materials, and products.</span></p> <p> </p> <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Perform data reviews/analyses, track metrics, and identify trends to inform release decisions, stability conclusions, and risk assessments.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Oversee drafting, reviewing, and approval of technical documents (protocols, SOPs, URS, trend reports, change controls, CAPAs, investigations) for regulatory readiness.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Facilitate collaborative approval workflows for documents, coordinating with third parties as needed.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Produce and quality-check reports, trend analyses, and investigative summaries; maintain traceability and audit readiness.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Conduct USP/JP/EP/Eurachem compliance reviews; support regulatory submissions and internal audits.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Lead CAPA generation and closure documentation, Out of Specifications, Out of Trend, GCC, and deviations; investigate with root-cause analysis and preventive actions.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Manage stability programs and studies (forecasts, scheduling, timelines); provide stability/testing planning (protocols, strategies, data interpretation).</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Engage cross-functionally on data-driven decisions; support raw material qualification; compile GMP data for COA; serve as client-facing scientific reviewer/writer.</span></li> </ul> <p> </p> <p><span style="font-family:verdana, geneva, sans-serif"><strong>Who You Are: </strong></span></p> <p><span style="font-family:verdana, geneva, sans-serif"><strong>Minimum Qualifications:</strong></span></p> <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Bachelor’s Degree in Chemistry , Analytical Science, or related Life Science Discipline</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">9+ years in GLP/GMP analytical environments in Quality Control or Process and Development.</span></li> </ul> <p><span style="font-family:verdana, geneva, sans-serif">OR</span></p> <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Master’s Degree in Chemistry , Analytical Science, or related Life Science Discipline</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">7+ years in GLP/GMP analytical environments in Quality Control or Process and Development.</span></li> </ul> <p> </p> <p><span style="font-family:verdana, geneva, sans-serif"><strong>Preferred Qualifications:</strong></span></p> <ul> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Detail-driven, data-focused professional who conducts independent review and oversight of stability, testing, and technical documentation to ensure scientific rigor, regulatory compliance, and timely decision-making.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Strong data interpretation, method monitoring, and documentation quality assurance to support material and product lifecycle activities. </span></li> </ul> <ul type="disc"> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Experience with or understanding of analytical methods such as UHPLC, CE-SDS, ELISA, PCR (ddPCr &amp; qPCR), and Cell Culture.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Academic or industry-based background in Virology.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Technical Skills: Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); method validation/transfer; data trending and statistics; instrument maintenance; basic programming or data analysis tools a plus.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Regulatory/Quality: Knowledge of cGMP, ICH guidelines, and QA/QC systems; experience with regulatory submissions and deviations/CAPAs.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Soft Skills: Excellent scientific communication (written and oral), problem-solving, collaboration, adaptability, and mentoring ability.</span></li> <li style="font-family:verdana, geneva, sans-serif"><span style="font-family:verdana, geneva, sans-serif">Biologics/Virology background; experience with microbial testing, QA release testing, and GMP documentation</span></li> </ul> <p> </p> <p> </p> <p><span style="font-family:verdana, geneva, sans-serif">Pay Range for this position: $66,200-$99,300.</span></p> <p><span style="font-family:verdana, geneva, sans-serif">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><span style="color:white">RSREMD</span></p> <p><span style="color:white">RSREMD</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>

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