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CGMP, validation and FDA industry experience desired. Primary Responsibilities: Troubleshooting of: Allen-Bradley ControlLogix, CompactLogix and SLC-500 PLCs, Rockwell Automation FactoryTalk View ME HMIs, Rockwell Automation FactoryTalk View SE SCADA Systems and Rockwell Automation Historian SE systems.
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Position Responsibilities: Perform cGMP analytical testing (bioassay, flow cytometry, qPCR, ELISA, and UPLC) Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
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Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, or process batching equipment in a cGMP compliant manner, using HMI/SCADA interfaces. The Line 4 Technical Lead position is responsible for front line troubleshooting, process improvement oversight / execution, basic to intermediate maintenance, and as needed operation of high speed equipment used in the production of BacT/ALERT bottles in a cGMP compliant manner.
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Minimum of 5 years working in a cGMP manufacturing environmentMinimum of 5 years working in industrial mechanical HVAC and refrigeration equipment. Who You AreKnowledgeable of cGMP HVAC systems with comprehensive refrigerant trouble-shooting experience.
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This role will provide exposure to biopharmaceutical manufacturing operations in a cGMP manufacturing facility which also includes pre-quality review and material usage reconciliation. Supporting Operational Excellence initiatives in support of cGMP production runs.
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Keywords: Microbiology, Bioburden, Microbiologist, QC, Endotoxin, Environmental Monitoring, cGMP, Microbial Tests, cGMP, Aseptic Technique, Pharmaceutical, Growth Promotion. 1+ years of experience working in a cGMP microbiology laboratory is preferred.
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ResponsibilitiesExecute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelinesIndependently develop and evaluate methodologies, design and implement experiments.
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Demonstrated understanding of cGMP regulations related to QA Warehouse and Inspection applications. This person will support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections including ID testing, sampling of raw materials/GMP supplies (components, printed packaging materials, etc.
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General understanding of cGMP, ISO and ICH guidance’s in the biotech manufacturing environment. Ensures manufacturing operations are within cGMP and GTP regulations and company procedures.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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RESPONSIBILITIES: Experience with and good working knowledge of current Good Manufacturing Practices (cGMP) and SOP's is required. Are you looking to make a career change to a rapidly growing, stable, innovating company.
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This position supports scale-up, technology transfer of AskBio's portfolio of gene therapy products into cGMP manufacturing for clinical production, process validation and commercial launch. Collaborate with cross-functional teams to transfer all unit operations of a gene therapy processes from Process Development into the MSAT laboratory and cGMP production to demonstrate successful knowledge transfer.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Beam is seeking a highly motivated Engineering Co-op within the Engineering and Facilities (E&F) team to support Process Engineering and Automation projects at our cGMP cell and gene therapy site in RTP from July through December 2024.
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Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Part brand ambassador, part clinical technician. Employee assistance program (EAP.
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The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.
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