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An Operator II is proficient in the set-up, start-up, continuous operation and shutdown of the assigned manufacturing equipment and processes using adherence to Standard Work Instructions, Good Manufacturing Practices and current Good Documentation Practices.
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The candidate for this position is required to maintain accurate and efficient laboratory records and ensure operations adhere to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP.
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Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements. Lead the document control program to ensure procedures meet CGMP requirements.
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Understand and follow all safety policies, company policies and standard operating procedures including but not limited to current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP.
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Follows established procedures including standard operating procedures (SOP’s), cGMP, food safety regulations, and safety procedures. Effectively manage the inventory levels for the commodities the Purchasing Assistant is responsible for.
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Meticulously documenting processes in corresponding batch records and log sheets, adhering to cGMP and established Standard Operating Procedures. Knowledge of cGMP operations is preferable.
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The QA/QC Manager will have responsibility for the implementation and management of quality control/assurance programs, processes, and technicians for Vireo Systems operations to maintain compliance with all applicable regulatory and cGMP requirements.
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A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
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Review and oversee the development and/or revision of Standard Operating Procedures related to cGMP quality and regulatory compliance. Knowledge of cGMP regulations and current industry trends related to pharmaceutical products.
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The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.
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Participate in laboratory clean-up and ensure adherence to cGMP, GLP, and safety policies and procedures. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
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Reviews approval of QC Standard Operating Procedures and Change Controls to ensure compliance with cGMP requirements. Expertise in Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
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Analytical development studies for pMDIs and DPIs following cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies. ; analytical development studies for pMDIs and DPIs following cGMP, Lupin EH&S and other relevant guidelines.
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All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs.
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