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Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP’s (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
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Ability work with cross functional departments like, Mfg. Assembly, Integration, Qualification and testing. Experience working in product development environment & Prototyping Previous experience with FDA/FAA requirements.
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All testing is performed in accordance with laboratory policies and procedures, FDA, CAP, OSHA, CUA, and Joint Commission regulations and guidelines. The medical laboratory technician, under minimal supervision, is responsible for independently performing complex laboratory tests on blood, body fluids, cells, and tissues that includes standardized microscopic, chemical, and/or bacteriological testing.
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Safeguard all company assets, including intellectual property, against theft and/or damage through effective employee training, testing and certification programs and strict enforcement of company security and plant visitation policies.
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Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements. Perform the set-up, calibration, testing and troubleshooting of reagent components and instruments.
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Perform analytical testing using instrumental and wet chemistry procedure. Comply with FDA, USDA, and GMP policies. The Quality Control Technician's role is to perform laboratory/quality functions by testing, collecting data, and analyzing findings on raw materials and finished goods.
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75% Grinds feed mill samples and prepares fecal and gut samples as part of routine testing programs. Performs basic preparatory procedures on feed samples containing pharmaceutical ingredients according to FDA cGMP requirements.
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Chemistry, Hplc, uplc, Gmp, Laboratory, Analytical chemistry, Formulation, Method validation, Development, Wet chemistry, waters hplc, empower, Quality control, R&d, Icp, ich gcp, fda compliance, documentation control.
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Hplc, in process analysis, raw material testing, gcms, ftir, fda, chemistry. hplc,in process analysis,raw material testing,gcms,ftir,fda,chemistry. Perform and/or assist with analytical testing of raw materials, in-process samples, and finished products.
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Understanding relevant industry standards, regulations, and compliance requirements (e.g., ISO, FDA, FCC) applicable to validation activities is beneficial. Familiarity with testing tools, equipment, and software used in validation activities, such as oscilloscopes, multimeters, data acquisition systems, and test automation tools.
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4) Familiarity with regulatory compliances such as REACH, RoHS, WRAS, NSF-61, and FDA.5) Familiarity with hard coating technologies such as HVOF, CVD, and PVD.6) Hands-on experience with chemical compatibility and corrosion assessments.
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Iovance is seeking a highly motivated individual for the position of GMP Quality Assurance Associate, Documentation at Iovance's IOVA facility (700 Spring Garden St) located within American Red Cross in Philadelphia, PA. This position is responsible for the Quality Assurance documentation related activities in support of the manufacturing/testing operations and ensuring compliance to quality objectives and regulatory requirements.
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Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation.
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Quality control, Microbiology, laboratory, Quality assurance, Gmp, Biology, Environmental monitoring, Cell culture, fda, titration, sop, pcr, cgmp, batch record, qc. Purity testing, viscosity, appearance, pH and specific gravity on adjuvant samples.
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Performs Weight Check and Quality Attributes Inspection of the product through the packaging process in compliance with company policies / procedures, FDA and cGMP regulations. Support validation and manufacturing studies including special sampling and testing.
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