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The QA Specialist conducts QA audits of BIO laboratories and functions including but not limited to ongoing process, data review audits, technical report, and study independent facility / process.
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Review traffic studies and roadway, intersection and traffic signal designs. Preparation of traffic impact studies including data collection and intersection and roadway capacity analyses using HCS, Synchro, and SimTraffic software.
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Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, leachables/extractables, particle analysis, stability, and/or microscopy/investigation.
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Attend and present at municipal planning, zoning and other board meetings\ Previous knowledge/experience with PennDOT and area counties/municipalities design regulations and permit requirements. Knowledge of traffic analysis procedures including trip generation computation, Synchro software and AutoCAD Civil 3D.
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Assist with clinical study activities such as study start up, investigator meetings, data review, etc. Our Corporate, Consumer Health, Medical Devices, and Pharmaceutical teams leverage data, real-world insights, and creative minds to make life-changing healthcare products and medicines.
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Study start up experience is necessary – it is important the candidate is able to review a protocol and work with our DM vendor to review CRFs, data capture systems and ensure those systems comply with the protocol.
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This position will be responsible for the review and interpretation of analytical testing data as well as protocols and reports, with an emphasis on scientific validity and adherence to FDA, EMEA, ICH and JP guidelines.
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Create, review and/or approve internal validation (VMP, URS, IQ, OQ, PQ protocols, reports, etc), and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
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Review of Quality Control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product. Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.
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Perform experiments and data review according to SOPs and protocols. Please review the job description below and contact me ASAP if you are interested. Cell culture and aseptic technique, cell-based potency assays, ELISA, FRET, qPCR, or plate-based biochemical assays (impurity, HCP), or flow cytometry.
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ELISA, FRET, qPCR, cell culture and aseptic technique, cell-based potency assays, flow cytometry or plate-based biochemical assays (impurity, HCP). Excellence in bioassay trouble shooting is preferred.
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4) Management of Bioanalytical documentation 5) Review of Data Transfer Agreements and work on Data Reconciliations. 2) Reviewing result tables against data packages 3) Preparation/review of assay/validation plans, reports, and methods.
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Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally. N2S Healthcare is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region.
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The MA is responsible for coordinating patient flow by assisting in clinical data collection and review for patient intake, ensuring the appropriate information is available to the provider, and entering pertinent history in the medical record.
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Company/Industry Related Knowledge: Pharmaceutical experience including understanding of Medical Affairs including clinical trials (e.g. ISS, CR, Secondary Data Collections, PASS, NIS, Registries.
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data review jobs in Exton, PA
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