• Aequor (Devers, TX)
    …manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and ... records. Perform real time review of manufacturing batch records. Review manufacturing shop floor documentation . EDUCATION REQUIREMENTS High School Degree… more
    HireLifeScience (03/28/24)
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  • Merck & Co. (Rahway, NJ)
    …for and support batch processing readiness and execution activities.Prepare, review , and/or approve GMP Documentation as appropriate.Author/Approve Standard ... Job DescriptionPosition Description: Senior Specialist , Process Engineer The Small Scale Organics (SSO)...in equipment design and testing as well as preparation, review , and completion of GMP documentation .Support compliance… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    Specialist , Global Development Quality Operations - API,- is responsible for review and approval of documentation to support Good Manufacturing Practice ... in support of our company's clinical supply programs. This person will also review and approve documentation accompanying the disposition of API materials… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …, Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice ... of our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering, ... production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:The automation engineer… more
    HireLifeScience (03/19/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …data integrity. Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation . Participates in ... in the treatment of multiple myeloma. Legend Biotech is seeking Systems Engineer Specialist as part of the Commissioning and Qualification team based in Raritan, NJ.… more
    HireLifeScience (03/22/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …accurate and performed in a timely manner in accordance with the procedures. Review and inspect documentation in support of Final Product Shipments. Generates ... Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in...and record results to complete receipt process. Reviews inspection documentation (C of A or other Material Certifications) for… more
    HireLifeScience (03/13/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and ... for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support… more
    HireLifeScience (03/20/24)
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  • Aequor (Thousand Oaks, CA)
    …Quality Control Testing. As a Product Quality (PQ) Quality Assurance (QA) Specialist , you will actively provide quality assurance support to the PQ organization ... Quality and Process development on projects, issue resolution and investigations. The QA Specialist will be encouraged to use technical abilities to lead and deliver… more
    HireLifeScience (03/02/24)
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  • BioAgilytix (Durham, NC)
    …at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the ... OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and work closely with the scientific staff to ensure data… more
    HireLifeScience (03/15/24)
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  • Aequor (Thousand Oaks, CA)
    …Practices, forms, checklists, guide, and related technical and business process documentation . When creating, updating and enhancing the documentation , adhere ... to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (eg, CD,… more
    HireLifeScience (03/13/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …and other regulatory requirements are adhered to as it relates to review and approval of engineering/validation specific documentation . He/she must ensure ... The QA Specialist II - Engineering/Validation is responsible for cGMP...the Engineering and Validation departments. Job Responsibilities Perform Quality review /approval of URS, FAT, SAT, IQ,OQ,PQ protocols and summary… more
    HireLifeScience (02/08/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …Are you ready to realize your potential? The Position This position will review manufacturing and support documentation and records to certify compliance with ... for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support… more
    HireLifeScience (02/29/24)
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  • Novo Nordisk Inc. (Durham, NC)
    …The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for ... Support systematic problem solving related to equipment qualification Reviews documentation for accuracy & completeness Contribute to process confirmations Maintain… more
    HireLifeScience (03/08/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Metrology Specialist as part of the Maintenance & Metrologyteam based in Raritan, NJ. ... standards, parts and spare parts are identified and available. Performs work review , approval and close out of work orders, including management of third-party… more
    HireLifeScience (02/15/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …the treatment of multiple myeloma. Legend Biotech is seeking a QC Microbiology Specialist , Lentivirus CAR-T Manufacturing as part of the Quality team based in ... Raritan, NJ. Role Overview The QC Microbiology Specialist , Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt...successfully transfer LVV manufacturing process to cGMP facility Create, review and approve relevant QC documents, SOP's and WI's… more
    HireLifeScience (01/09/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …data integrity Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation Participates in ... of multiple myeloma. Legend Biotech is seeking a CQV Specialist or CQV Associate as part of the Technical...601, and 610 is preferred. Experience authoring and executing documentation including but not limited to: Batch Records, SOPs,… more
    HireLifeScience (01/24/24)
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  • Novo Nordisk Inc. (Durham, NC)
    …Novo Nordisk and help us make what matters. The Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & ... other documentation (in conjunction with LoB) & QA presence &...Handles release of raw materials & provides quality oversight, review & approval of validation activities associated with minor… more
    HireLifeScience (02/07/24)
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  • Novo Nordisk Inc. (West Lebanon, IN)
    …for the coordination of process/equipment improvements and data trending/analysis Review /approval of completed process documentation Ability to train ... to support manufacturing operations. Focus areas may include Training, Documentation , Deviations, Change Control and Projects. Drives the coordination and… more
    HireLifeScience (02/06/24)
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