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Good understanding of cGMP, ICH, FDA, and USP guidelines is essential, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines), and the ability to apply the guidelines in the context of the stage of pharmaceutical development.
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On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
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Instructor II must have a minimum of five (5) years recent experience working as a Certified Professional Controller in an FAA air traffic control facility, within the ATC option for which application is made.
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Troubleshooting and data review/interpretation will be needed in this role while working in compliance with cGMP/GLP, safety and regulatory requirements. Experience with other synthetic techniques below is a plus- Dissolution, UV-Vis, FTIR, NMR, GC, LCMS etc.
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The Endoscopy Center Processing Technician is responsible for the leak testing, manual cleaning, and high level disinfecting of all endoscopic equipment and accessories according to infection control guidelines and established Endoscopy Center guidelines.
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Quality Control, Supervisor We are looking for a Quality Control Supervisor to join our Wilmington, MA team! As our QC Supervisor, you will work with our production team in our Thermal Spray facility.
$85,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Project Controls Manager – Infrastructure
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The person in this role assists the MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products. Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing.
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The Senior QC Analyst will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs. Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
$62 an hourExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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B.S. or M.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 8+ years industry experience in analytical development and/or quality control in a pharmaceutical setting.
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Project Controls Manager – Infrastructure
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This position requires expertise in current Good Manufacturing Processes (cGMP), along with proficiency in Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) and relevant regulations.
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The QC Sample Management Analyst I plays a critical role in supporting day-to-day quality operations within the cGMP QC laboratories. Understanding of documentation practices related to cGMP and data integrity.
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DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.
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Experience in the following areas is important: system integration, processor selection, analog integration, sensor design and integration, data acquisition, sampling and control theory, digital signal processing techniques and low power design, signal integrity, power integrity.
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cgmp control jobs Company: Randstad Usa in Wakefield, MA
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