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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, processes and procedures to support GMP manufacturing. Working knowledge with USP/EP and cGMP/EU GMP.
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This position will report to the Head of GMP Quality and oversee GMP quality systems at RayzeBio Indianapolis. Minimum 5-7 years in GxP (GMP, GLP, GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility.
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Minimum 5 years of GMP Quality Assurance experience, preferably in a contract manufacturing organization. Perform review of facility cleaning records and other GMP records related to facility and equipment.
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Familiarity with FDA, EudraLex, and ISO regulations related to GMP manufacturing. 3 to 5 years of experience in a GMP manufacturing or other regulated industries. Manage and utilize the IFS/Computerized Maintenance Management System (CMMS) for accurate asset data management, including calibration and preventive maintenance schedules.
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ISPE; ASTM; EudraLex GMP Annexes; PIC/S; USP)Previous experience in GMP production sitesAbout Life SciencesOur Life Sciences team partners with global pharmaceutical and personal care manufacturers to enhance safety, compliance and operational efficiency through a comprehensive, programmatic approach to contamination control, cleaning and disinfection.
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Must adhere rigidly to all GMP policies and procedures as stipulated by the FDA. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
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B.A./B.S degree in Chemical Engineering, Biology, or similar relevant field with at least 6 years of direct GMP manufacturing experience in a biotechnology manufacturing facility or Pilot Plant OR a High School Diploma with 10 years of experience in protein purification in Biotech/Pharmaceutical industry.
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Ensure safe and smooth operation of Kilo lab understanding engineering equipment, GMP, quality and computer operations in chemical scale up environment. Responsible for contributions to the scale up of APIs under non-GMP and cGMP manufacturing in the Process Chemistry Kilo Lab (PCKL.
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1+ years in a GMP or FDA regulated industry. Seeking a QA Documentation Specialist for our client! 2+ years in document review or laboratory testing. 1+ years in a GMP or FDA regulated industry.
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As a member of UDC’s Chemical Business, this position will work closely with UDC’s HQ team, UDC’s contract manufacturing partner (PPG), and other UDC subsidiaries in the development and manufacture of UDC’s OLED materials in a fast-paced, non-GMP environment.
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Knowledge and interpretation of Good Manufacturing Practices (GMP) and quality systems is required. Manage the Quality Management Systems (Track Wise, ComplianceWire, Master Control, etc. Quality Assurance Specialist Jubilant Cadista Pharmaceuticals, Inc.is located in Yardley PA and is a Jubilant Life Sciences Company, a global healthcare company with a wide range of products and advanced technologies.
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Experience working in a regulated (GLP/GMP) environment in preferred. Executes experiments and analyzes data from flow cytometry analytical assays with limited supervision, as part of the Cell Therapy Analytical Development (CTAD) team.
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As GMP QA Associate Director you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. Associate Director, QA GMP page is loaded.
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The Facility & Reliability Engineer will also support the successful operation of facility, laboratory, and business functions at multi-use GMP West Cell Therapy Operations, through interaction with internal customers and external service providers.
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