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Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products. Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system.
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Job Overview: This role, for a Document QC Specialist Contractor, will manage the quality control of scientific documents and Bioanalytical data for the Translational DMPK and Clinical Pharmacology group.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
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The ideal candidate will have hands-on experience in WB, ICC, FC, and Elisa techniques. Validate antibody performance using WB, IHC, ICC, FC, IP, Elisa, and IgG concentration at the QC stage for Reagent projects.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs. Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH [International Conference on Harmonization] and other regulatory guidelines.
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BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Validate antibody performance using sandwich ELISA at the QC stage for kit pair antibody projects. Maintain high-quality standards within the lab, ensuring compliance with all external and internal quality standards, as well as health and safety guidelines.
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Support on key Quality Committees, such as Compendial Change Control, Document Change Control, or Stability Review. Provide technical and guidance in lab support to manufacturing, multiple QC laboratories and the overall Quality Organization to resolve test issues, conduct OOT/OOS investigations, identify and improve problematic methods, and drive innovation.
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Associates, Bachelors, or Masters graduate with 1+ years of experience in a quality control environment performing data review/analysis of chromatography and spectrometry methods. Enhance QC initiatives through the identification and implementation of best practices in data review and analysis.
$25 - $32 an hourExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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O BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
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Hands on Data Engineering Manager. As a Hands-On Engineering Manager, you will play a pivotal role in leading our small but highly skilled engineering team to drive technological innovation and support our rapid growth trajectory.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Hands-on experience and knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy. The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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This role is critical in developing a strong partnership with enGene’s CDMOs and CTLs in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Quality Control operations at external testing sites, with focus on method validation, method troubleshooting, life cycle management, and supporting tech transfer and comparability activities.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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We are looking for a Quality Control (QC) professional to join our team as a Senior Quality Control Analyst, supporting our internal GMP cell therapy manufacturing. The Senior QC Analyst position interacts regularly with TScan’s Quality Assurance, Analytical Development, Process Development, Manufacturing, Facilities, as well as TScan’s external test laboratories, where applicable.
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Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities. Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company.
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quality qc manager hands on jobs Title: quality control tech in Bedford, MA
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