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Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 6-8+ years of analytical development & quality control experience with complex biologics, particularly Fc-fusion proteins and monoclonal antibodies from early to late-stage development (or equivalent combination of education and experience.
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Experience using source control (Azure DevOps, GitHub, or similar) The Experienced Senior Software Developer will work with cutting edge technology, deliver high quality solutions across various local industries, and drive solutions with a team working on holistic software projects that range in size and scope, as well as receive continuous career development opportunities.
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Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems.
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The Director of R&D Quality, GCP - Cell Gene Therapy (CGT) reports directly to the Head of RDQA and is a trusted advisor and partner to clinical and quality stakeholders and business partners.
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Collaborate with Project Control to review purchase requisitions in Deltek Costpoint prior to approval for procurements. We deliver real change and measurable results through our diverse, high-performing teams, quality work at the highest professional standards, operational know-how from across our global organization, and creative and bold ideas that drive innovation.
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Ensure the effective execution of quality control procedures throughout the entire product lifecycle (design, development, manufacturing, distribution, post-market surveillance) Oversee the implementation of Supplier Corrective Action (SCA), complaints, corrective and preventive action (CAPA) processes, and Non Conformance Reports Develop and maintain a strong quality culture within the organization, fostering employee ownership and commitment to quality.
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Clean and provides low and high level disinfection of all procedural equipment, including use of Trophon machine following MGH infection control guidelines. Involved in unit quality assurance regarding documentation and core responsibilities related to CFA role.
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Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues on time.
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The Lead Radiation Therapist will assume responsibility for specific activities related to maintaining the overall quality control of treatments, and the orientation, education, and supervision of Senior and Staff Radiation Therapists in the Department of Radiation Oncology.
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In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations.
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Lead global CMC and Quality key initiatives and represent Pharm Sci to other cross functional stakeholder key initiatives. Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global reporting.
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Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops) Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes.
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The Director of Pharmacovigilance Quality and Alliance Management will be a pivotal member of the Pharmacovigilance (PV) team, responsible for ensuring the highest standards of drug safety and compliance within Aveo Oncology.
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We prioritize the needs of our travelers, giving you complete control over your journey. Traveling Registered Nurse, Travel, ER, RN – ER, Contract, Travel, Traveling Nursing, Assignment, Registered ER, Emergency Room Nurse, ER RN, Emergency Room Nurse, ER Travel Nurse, Healthcare RN, ER Nursing, Nurse RN, RN Nurse, Contract RN.
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The Quality Control Inspector will perform Required Inspection Items (RII) work in lieu of the Chief Inspector, as well as Boroscope Inspections, Non-Destructive Testing (NDT) Inspections and other duties assigned.
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quality control jobs Title: advisor Company: Cigna in Waltham, MA
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