The Senior Specialist, Product Disposition will support the timely and compliant disposition of all the company Gene Therapy products across all stages of manufacturing. The Senior Specialist will bring strong attention to detail, a quality-first mindset, and the ability to work cross-functionally in a fast-paced, regulated environment.
Acts as an advocate and subject matter expert guiding the business by serving as a quality champion through measuring and monitoring the quality and effectiveness of work processes in claim processing and customer service that impact customer satisfaction, medical cost management, and operational efficiency. Acts as a subject matter expert on Quality Specialist workflows, policies, systems requirements, and enhancements as well as daily operations and programs to consistently drive optimal results.
p>In accordance with the law "Informatique et LibertƩs" of January 6, 1978 amended several times, in particular by the GPDR, we invite you to consult our Confidentiality Policy, which will indicate all the useful information on how we treat and protect your data, your rights in relation with them (access, modification, deletion, opposition to processing, etc.), the purpose of the data collection, how to get more information, etc. In addition, they add significant contributions to physics and space research, drug discovery, proteomic technologies, imaging, and communications through our dedication to continual technology advancements.
p>Qualifications: ā¢ Required qualifications: Bachelor's degree in Life Sciences, Engineering, or a related field ā¢ Minimum of 8 years experience in Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs ā¢ Medical device industry experience required ā¢ Extensive knowledge of FDA, ISO, EU MDR, and medical device quality requirements governing human subject research ā¢ Excellent organizational, execution, and communication skills. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs.
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.
Description: The Senior Quality Assurance Specialist will provide Quality Assurance (QA) oversight and support to Manufacturing, Quality Control, and Process Development, Technical services and other teams for both onsite or externalized manufacturing and testing, technology transfer, and other CMC development activities. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.
p>We are seeking a Quality Compliance Senior Specialist who will be responsible for overseeing and authoring Annual Product Quality Reports (APQR) for Lantheus commercial products, performing internal Quality System audits, leading the Compliance Surveillance Review Board, authoring and revising Quality System Documentation, as well as supporting document control activities including overseeing the document life cycle management of corporate policies and procedures within the Lantheus electronic quality management system. Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes.
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Our products include advanced surveillance sensors, unmanned air and ground vehicles, sensing devices used to detect chemicals, biological agents, radiation and explosives, and a host of other solutions that help warfighters, first responders, and search-and-rescue teams do their jobs better. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP), ensuring accurate and timely maintenance and review of batch record documentation and authoring or reviewing departmental SOP's and Work Practices.
li>Support or perform disposition of advanced oligonucleotide products for pharmaceutical use, including pharmaceutical intermediates, active pharmaceutical ingredients (API) and adjuvants/constituent materials in accordance with approved specifications and procedures, including Avecia Enterprise Resource Planning System (SAP) transactions. About this opportunity : The Quality Assurance Specialist III is responsible for interfacing with and provide quality input to client's manufacturing programs that are in early stages of development or manufacture customized medicines.
p>Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.
p>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.
Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.
p/> The Quality Control (QC) Specialist, LIMS Master Data Builder arranges the creation and modification of LabVantage LIMS master data. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law.
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