- Legend Biotech USA, Inc. (Raritan, NJ)
- …all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop ... and remediation's.Lead continuous improvement projects to reduce turnaround time for batch review / release.Require minimal direction to complete tasks,… more
- Aequor (West Greenwich, RI)
- … review and approval of cGMP processes, procedures, documents and records . Review logbooks, batch records , attachments, work orders, and other GMP ... Experience with analytical testing and/or general compendia testing Experience working with batch records and other GMP documentation Knowledge of data integrity… more
- Aequor (West Greenwich, RI)
- … review and approval of cGMP processes, procedures, documents and records . Review logbooks, batch records , attachments, work orders, and other GMP ... from established procedures are documented per procedures. Ensure that production records and testing results are complete, accurate, and documented according to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and ... audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance Review… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records , supporting test records and ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …department leaders. Review and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments. Review and participate in ... quality event records , such as Change Controls, Deviations, and CAPAs.Develop and implement strategies to improve aseptic manufacturing processes.Collect required samples needed for testing as required.Follow all required work safe practices.Hold peers… more
- Aequor (Waltham, MA)
- …Excel, Outlook, PowerPoint, and Project. This role will be: Reviews executed batch records and related documentation, resolves compliance issues and dispositions ... for use in clinical trials Perform lot release Quality Review of manufacturing and quality control records ...Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Ensure… more
- Merck & Co. (Durham, NC)
- …of facility. Author, review , and/or edit operations and technical documentation ( Batch Records , SOPs, Job Aides, training, and engineering documents) to ... Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will create/revise operational procedures, including manufacturing work instructions, master batch records , forms, etc. This individual will be ... of daily production schedules. This individual will also lead facility operating review meetings and own various department projects to drive continuous improvements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Annual Product Review (APR). Review and approve SOP and Batch record revisions.RequirementsBS/BA required in technical discipline: Engineering, science or ... similar fieldA minimum of six (6) years of professional relevant business experience.Demonstrated experience in completing complex investigations independently.Knowledge and solid understanding of cGMP regulations and FDA/EU guidanceAbility to learn and… more
