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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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Develop and execute a comprehensive immediate and short term strategy to grow and support key customer accounts within gene reading and synthetic biology. The Director Strategic Transformation is responsible for project management of IDT’s Policy Deployment (PD) initiative aimed at maintaining IDT’s position as the partner of choice for custom oligo and enzyme solutions in the genomics market.
$175,000 - $200,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Keywords: QC Laboratory Tech, QC Lab Tech, Biology, Biochemistry, Bachelors, LI Injections, SOP, GMP, QC testing, Assay, Reagents, Buffers, ELISA, ELISA assays, Western Blots, Cell Culture, Biotechnical Research, Biotechnical, Clinical Stage, Pharmaceutical, Neck Cancer, Head Cancer.
$17 - $18 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing.
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Work with R&D and tech transfer team for successful transfer of Programs into the GMP area. Ensure slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment. Work with R&D and tech transfer team for successful transfer of Programs into the GMP area.
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Expertise with USDA, FDA or GMP Guidelines. Ensure operations are in compliance with GMP Standards and FDA Regulations. LEAN/Six Sigma Certifications such as Green Belt or Black Belt preferred, but not required.
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The ideal candidate will be responsible for overseeing all aspects of manufacturing engineering activities, ensuring efficient production processes, implementing TPM methodologies, and maintaining compliance with GMP (Good Manufacturing Practices) standards in our facility.
$130,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our Gene Therapy facility, located at the University of Maryland (UMD) BioPark in Baltimore, MD, specializes in upstream and downstream process development of viral vectors for clinical applications.
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Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP) Perform routine assembly-line production functions of filling, packing, assembling, labeling and inspecting.
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Evaluates operating process equipment and implantation to ensure constant compliance with standard manufacturing practices (SMP) May develop weekly production plans coordinating resources (raw materials) and communicating relative priority to downstream parties.
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BS or BA degree in Science or Engineering with 5-10 years of GMP experience with at least one year in an FDA regulated industry. The QA Specialist I, Batch Release is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the CGMP operation of Emergent BioSolutions in Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements.
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To review and approve quality system documents to ensure that they comply with relevant SOPs, are GMP compliant and meet regulatory requirements. This position is responsible for performing a role in any one or more of the following functions: Quality Systems (Change Controls, Complaints, CAPAs, Investigations and Supplier Quality) and Compliance in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.
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Catalent focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing.
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Benefits: Weekly Pay Competitive salary Health insurance Opportunity for advancement Major Responsibilities:To oversee the adherence of GMP policies and Food Safety Prerequisite Programs, by monitoring production personnel and the facility.
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Requirements: High School Diploma Experience handling liquid and dry chemicals preferred Must be able to wear PPE Must be able to stand for most of the day Experience working within a GMP or food-regulated environment preferred Experience working with SDS preferred M3.
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