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Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development.
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We are seeking a highly skilled and detail-oriented GMP Test Technician to join our team. The GMP Test Technician will play a crucial role in maintaining the highest standards of quality assurance in a regulated manufacturing environment.
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Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem solving techniques.
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Proven experience as a GMP Test Technician or similar role in a regulated manufacturing environment. Identify opportunities for process improvement and efficiency in GMP testing procedures.
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Job Title: GMP Business Analyst. SAP Fiori App integration. Plant Maintenance Master Data: Equipment/Functional Location/Maintenance. Able to create SAP reports from Plant Maintenance Master Data.
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GMP or GLP and/or FDA manufactured component experience/knowledge preferred. Mitsubishi Chemical Performance Polymers, Inc. (MCPP) a subsidiary of Mitsubishi Chemical is wholly owned, MCC and its twenty group companies provide products and services to customers in North and South America providing a broad range of businesses including chemical, petrochemical, composite materials, pharmaceuticals, electronics, and other businesses.
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1 - 3 years GMP/GLP experience. Electro-Mechanical assembly skills. The Electronics Assembly Technician I is a non-exempt position that reports to the Electronics Management Team. The Electronics Assembly Technician I is responsible for assembling and testing full assembly and individual sub assembly parts for Charm Sciences equipment.
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In this role, the Molecular Biology Quality Control Analyst I will be responsible for supporting the gene therapy program pipeline, including but not limited to routine GMP testing of AAV vector analytical methods such as GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed.
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Position : Packaging Operator (Must Have Clean room, GMP & SOP Exp) Some Clean Room experience, Knowledge of Computer basics and GMP knowledge. Position : Packaging Operator (Must Have Clean room, GMP & SOP Exp.
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Additional duties as may be assigned from time to time Education & Qualifications 4 years of experience in the pharmaceutical/biotech industry Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards.
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Strong knowledge of engineering standards and all applicable regulatory requirements including: Building Codes, Factory Mutual, Environmental, GMP/GLP, OSHA and ADA. In this position, the ideal candidate will work independently to lead cross-functional project teams through all phases of Infrastructure-Utility, Lab-Office and GMP Manufacturing projects- from scope development, design, CQV and close-out.
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Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent. Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent.
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Knowledge of GMP, FDA, ISO requirements. Experience working in a GMP/ISO environment. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team.
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Adhere to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Strong understanding of GDP and GMP. Excellent English communication skills. The primary responsibility of the Quality Inspector will be to ensure compliance with quality standards and regulations in a manufacturing environment, specifically focusing on paperwork, line clearance, 5S (Sort, Set in order, Shine, Standardize, Sustain), MPIs (Manufacturing Process Instructions), and QIs (Quality Inspections.
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The micro-cleaner is a critical role in the company which ensures the proper cleaning of the cleanroom, controlled environment and GMP laboratory environments. Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement.
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gmp job Company: Genoskin in Billerica, MA
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