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BS in a scientific or engineering discipline with minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits.
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Have a willingness to learn new things, possess skills in metrology and receiving inspection, prior experience in laboratory or technical field using chemicals proves useful, prior experience with statistical process control, measurement gauges of all types, good customer and communication skills at all levels, good positive attitude and work ethic.
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This role manages technical quality assurance, oversees manufacturing QA/QC practices, conducts inspections, and coordinates supplier audits, requiring expertise in GD&T, SPC, and strong communication.
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May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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Requires -7+years of progressive industry experience, with a solid background in process development, manufacturing, quality assurance, quality control, and CMC regulatory.
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This role is instrumental in executing our current supply planning and in helping us develop and implement our future capabilities There role collaborates closely with Process Development, Research, CMC, and Quality Control and Quality Assurance.
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Proficient knowledge of USDA/FDA regulations, 3rd party audits, GMP's, SSOP's HACCP, BRC, and process control. QA Technician will assist Quality Assurance Manager in ensuring compliance with all Manufacturing Quality and Food Safety Policies and Guidelines.
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Entegris is currently seeking a talented and innovative Production Engineer who will own sustaining and quality assurance activities for manufacturing products and lead continuous improvement projects to drive process efficiency and reduce product variation.
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Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to assure effective tech transfers and start-up of new manufacturing processes according to agreed upon timelines in support of business objectives.
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Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Geometric Dimension and Tolerancing (GD&T), Reading engineering prints, technical reports, raw material specifications, acceptance test Reports, Quality Assurance Inspection of Received Goods, Measuring Gauges / CMMs / Micrometers, Height / Plug / Thread gauges, Go / No-Go gauges, Statistical Process Control (SPC.
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As a Quality Inspector (also known as Quality Control Technician, Quality Assurance Associate), you'll conduct inspections and tests on in-process and finished products, ensuring that quality standards and process controls are met throughout the manufacturing process.
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Minimum of 7-10 years quality assurance / supplier quality engineering experience in a pharmaceutical/life-science environment. Provides Quality support and Technical direction for New Product Development, technology transfer, and process validation activities.
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A Testing and Quality Assurance is needed for an American defense, aviation, information technology, and biomedical research company in the Tewksbury, MA area. Statistical Process Control (SPC.
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quality control process assurance jobs in Bedford, MA
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