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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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Create digital game tiles of varying sizes Work with QA for daily smoke tests and game release testing Write search-engine optimized game descriptions for current and new games Assist in the maintenance of the games roadmap Assist in the creation and maintenance of documents required for regulatory compliance in different jurisdictions.
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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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Certified as an Anti-Money Laundering Specialist by ACAMS or equivalent AML certification/license/audit/control testing certification (is a plus) Minimum 3-5 years of experience in financial crimes/AML compliance testing, Audit or similar related QA/QC testing experience.
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Provides direct supervision to QA Technician / Specialist team in support of structured product inspection programs, laboratory testing, environmental monitoring, and calibration activities.
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Master’s degree in Biotechnology, Regulatory Science, Pharmaceutics or Pharmaceutical Science or Industrial Pharmacy (or its foreign equivalent); plus 6+ years of quality assurance experience within the pharmaceutical drug development industry as a Quality Assurance Manager, Lead, Specialist or Associate.
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As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records.
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This position provides direct supervisory oversight of Supplier Quality Specialist, Sensory and QA Raw Materials staffing. This individual works closely with members of Plant Management, Food Safety and Sensory, Regulatory Affairs, Operations, R&D, Culinary, and Sourcing and leads the Food Safety/ Team. This position is designated as the SQF Practitioner.
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As a QA Document Specialist II, you will play a pivotal role at Penumbra providing timely and accurate support of quality processes related to Document Services to ensure compliance with Penumbra procedures and regulatory requirements.
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Primary responsibility will be to conduct QA testing on AML investigations, Sanctions, Due Diligence, and/or KYC in order to provide guidance on various components of the operational work output to ensure the output of these units are being conducted in an efficient manner with adherence to guidance, policies, procedures, and regulatory expectations.
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Works under the direction of the Corporate QA Committee and reports directly to the Quality & Clinical Director (QCD). Reports are to be submitted for review to the QCD prior to the submission to the QA Committee.
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The QA Manager/TL is accountable for ensuring cGMP compliance within the site’s B1 Biological ABI/BPM/ Pharmaceutical and Pharma/Biopackaging Operations, is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives.
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QA/QC SPECIALIST - Environmental Lab, Chemistry & Fuels. Effectively maintain QA/QC programs to ensure the laboratory complies with standard operating procedures, regulatory requirements, and customer requirements.
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The QA Release Specialist III is responsible for performing various Quality Assurance activities related to the disposition of incoming materials working closely with other departments including Manufacturing, Materials Management, and Supply Chain.
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