div>Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Hybrid, Waltham, MA13 days ago
li>Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities. The selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
Founded in 2015 to develop the worlds first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. Act as the primary authority for lab throughput, providing Program Managers and stakeholders with accurate turnaround times and data-driven project timelines.
In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
div class="content-intro">The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.
Many people have worked in environments where you feel like just another nameless part of an enormous machine.
Lexington, MA30+ days ago
p>Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.