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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products.
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Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.
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This individual will support quality control activities related to custom raw material manufacture for RNA and AAV gene therapy products conducted both internally and at various contract manufacturing organization (CMO) sites.
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Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Analyst I, that will be primarily focused on wet chemistry, based onsite in our Andover, MA facility. The Quality Control Analyst I (RP/ISO) is responsible for conducting routine analysis of materials including: Raw materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs.
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Quality certifications like ASQ Six Sigma Green Belt or Black Belt, CQE, etc. Job Title: Quality Systems Engineering Manager Job Description:This position will require engagement across departments, ADI manufacturing sites, leading cross-functional audit teams, Quality Systems deployment and standardizing BKMs across ADI sites globally.
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The individual will devise, troubleshoot, and validate cell-based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
$96,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Pharmaceutical quality, GMP QA/QC compliance or laboratory experience; Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs. Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH [International Conference on Harmonization] and other regulatory guidelines.
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Ability to serve as Software Quality organizational spokesperson to other functions. Software Quality Engineering (SWQE), within Engineering Sustainment Quality Assurance (ESQA), provides solutions and services to the business.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Quality Technician Process Inspector needed for an opportunity with SOC's client to work in Wilmington, Massachusetts. Work closely with the program team to ensure quality standards are consistently met and maintained.
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The Supplier Quality Engineer is responsible for the overall supplier quality of specific suppliers, contract manufacturers and material commodities within Brooks. Supplier Quality Engineer.
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Identify supplier escapes/issues and ensure proper containment and backflow to the Supplier Quality Management team. Qualifications You Must Have:Bachelor’s in Science, Technology, Engineering, or Mathematics (STEM) or other technical field of studyMinimum of eight (8) years related Quality Engineering experience.
$96,000 - $200,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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QA Technician will assist Quality Assurance Supervisor and Manager in ensuring compliance with all Manufacturing Quality and Food Safety Policies and Guidelines. The Quality Assurance Technician must be able to interact across interdepartmental boundaries in a professional, pro-active manner, avoid conflicts and exemplify a collaborative spirit.
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Author and review SOP changes; participate in change controls, CAPAs and other quality systems. Work independently and as a team player with quality and attention to detail. Promote and actively demonstrate the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
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The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV). Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering.
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Title: quality Company: Lfb Usa in Tewksbury, MA
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