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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Associate Director, GMP Quality Control. Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
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Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials.
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Enhance quality control practices and optimize internal processes by contributing to the preparation, review and approval of standard procedures and electronic systems. Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e.g. Veeva.
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For CMOs with aseptic processing, review media fills, and environmental monitoring data as it relates to lot release, change control and facility re-starts. Review and approve Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS.
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Contribute to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
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Participate, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program. Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
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Quality leader and quality culture promoter within the global organization. 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.
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Team members will support both pre-clinical and GMP Quality Control release testing in a dynamic new company setting. We are seeking persons experienced in the Quality Control testing of biologics in a GMP setting.
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Quality Control Analyst. Collaborate with the QC Lead to ensure quality control. Oversee all aspects of quality assurance and testing for software and IT system releases.
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Ensure the quality system is effectively implemented including all prerequisite programs (e.g. BRC, HACCP, product safety and security, traceability, pest control, etc.) Experience using various statistical and quality methodologies including but not limited to Statistical Process Control (SPC), Statistical Quality Control (SQC), 5S, 8D, Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, Gage Repeatability and Reproducibility (R&R), and Design of Experiments (DOE.
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Manage, onboard, and lead the General Contractor BMS Lead(s), the Control Systems Integrator (CSI) and Electrical and Installation (E&I) controls contractor throughout all phases of the project, while developing program efficiency improvements and incorporating lessons learned to ensure a safe, robust, reliable and functional controls system that adheres to Facebook’s design and quality requirements.
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Experience with Industrial Automation and Building Management Control Systems (i.e. PLC/DDC). Meta is seeking a BMS Quality Manager to join our North American Data Center Design, Engineering & Construction team.
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Management and oversight of all Quality Control and Quality Assurance (QAQC) processes for incoming fabrication to the NEHP Integration Shop. We provide a broad range of products & services including liquid, chemical, and gas storage, blending, and delivery control, pre-fabricated high purity process utility modules, corrosive fume exhaust duct, and airflow control devices.
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Sample quality control (QC), next-generation sequencing (NGS) library prep and target enrichment, microarrays, CRISPR, PCR/qPCR, bioreagents, and data analysis solutions including interpretation, and reporting.
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quality control jobs Title: quality control analyst Company: Anthem
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