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Document all testing activities in accordance with cGMP.Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs. Job DescriptionThe Chemist I, Extractable & Leachable will perform material extractions, standard solution, and sample preparations to support GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices.
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Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Good knowledge of wet chemistry techniques In-depth working knowledge of laboratory software and chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax) Competency in Microsoft Office Suite P#1 Email resumes to Jacqueline.
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0 – 2+ years of experience in the field, preferably in a microbiology/chemistry labAseptic lab technique, pipetting, and working in a GLP (good laboratory practices) environmentIt would be a plus if you also possess previous experience in:Use of Microsoft Suite (Word, Excel, PowerPoint)Medical device testing experienceThe the hourly range for this role is $34 - $37.
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Experience with GLP and/or GMP and hands-on experience with HPLC and/or GC desirable. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Independently providing sample analysis support for clinical studies by delivering high quality data packages working in a GLP/GCP compliant laboratory setting. As an Immunogenicity Analyst, you will be responsible for the validation and sample testing of anti-drug antibody (ADA) and neutralizing antibody (NAb) assays for use in clinical studies in alignment with therapeutic area partners.
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Lead the development, review and User Acceptance Testing (UAT) of the Interactive Response Technology (IRT) system. Working knowledge of GMP/GCP/GLP/GDP regulations. The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP.
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Proficient in SOP, Protocol, Report authoring, Method validation execution using cGMP/GLP. Physical testing, pH, Conductivity, KF (Karl Fisher), Particle Size, Moisture Analyzer. Independent testing of raw material, in-process, finish product and packaging materials testing.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Performs study director functions outlined by FDA GLP (21 CFR part 58) for GLP studies, and serve as technical leader in ensuring proper execution of additional microbiology testing (bioburden, sterility, endotoxin, biological indicators, etc.
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Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures. Performs a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.
$34ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products.
$63,000 - $68,000ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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QA (GMP/GLP) team will be accountable for all aspects of product quality throughout development, both internally and in collaboration with CMOs and testing laboratories. The ideal candidate will have extensive experience leading GMP/GLP Quality Assurance activities and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GMP/GLP compliance during clinical development and commercialization of drug candidates.
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Training in a GCLP/GLP/GMP environment and other international regulatory guidelinesNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This position may require occasional weekend and evening work to meet critical business timelines.
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