- Daiichi Sankyo, Inc. (Bernards, NJ)
- …includes creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance ... areas centered around rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level.… 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 ... Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and ... based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities...logbooks.Responsible for storage and archival of GMP documents and batch related records .Perform tasks in a manner… more
- Merck & Co. (Rahway, NJ)
- …products.Author and review GxP documentation including but not limited to batch records , specification, equipment qualifications, change records and ... ultimately to enable flexibility and speed of our company's pipeline.This person will: Lead and strategically plan on-the-floor batch manufacturing to ensure… 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
- Insmed Incorporated (San Diego, CA)
- … lead planning activities for process characterization and PPQ planning activities. Review batch records , SOPs, raw material specifications, development ... reports and GMP protocols. Support change control and the change management of different process versions and comparability assessments for process changes. Qualifications/Requirements: BS, MS, or PhD in Biotechnology, Chemical or Pharmaceutical Engineering,… more
- BeiGene (San Mateo, CA)
- …quality is compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch related deviation handling in ... changes at CMOs **Essential Functions of the job:** + Lead Small Molecule and Large Molecule commercial product quality...implementation at CMO + Manage change controls + Perform batch dispositions + Perform PIP (Person in Plant) +… more
- BeiGene (Emeryville, CA)
- …quality is compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch related deviation handling in ... supply after commercialization **Essential Functions of the job:** + Lead Small Molecule commercial product quality team to ensure...implementation at CMO + Manage change controls + Perform batch dispositions + Perform PIP (Person in Plant) +… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and...expected metrics to ensure timely release to market. + Lead , mentor and coach site personnel on quality matters… more
- Curia (Albuquerque, NM)
- …industries. The Quality Program Management Manager will lead and manage our QA batch record review and product disposition team. The manager is ... the timely review and disposition of executed batch records (clinical, commercial, and media fills)....more! Responsibilities: + Lead and manage QA batch record review and product… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …to procedures and policies, including coaching and mentoring operators and technicians on proper batch record documentation. + Lead and participate on safety ... Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging...+ Perform Change Controls + Identify, implement and execute SOP/Form/ Batch Record revisions + Lead … more
- University of Oregon (Eugene, OR)
- …analyzing and describing the content of library resources for the public catalog; batch -loading records for e-resource collections; ensuring the quality of data ... Your expertise will guide the training of library staff in cataloging, record maintenance and evaluation, and large-scale batch project management. You… more
- ThermoFisher Scientific (St. Louis, MO)
- …professionals and play a vital role in the flawless execution of manufacturing batch records , work instructions, and SOPs. Your keen attention to detail ... A day in the Life: + Execution of manufacturing batch records , work instructions and/or SOPs, with...Documentation of all activities to meet cGMP requirements. Daily record review , tasks, and databases. + Complete… more
- Danaher Corporation (Fargo, ND)
- …GMP oversight, and "real time" review of manufacturing documentation including batch records and protocols during execution. Monitor and auditing processes ... and report to the Manager, Operational QA. The OQA Lead activities include but are not limited to training,...met. + This role performs timely reviews of all batch documentation; assure that batch records… more
- ThermoFisher Scientific (St. Louis, MO)
- …such as document searches, review and approval, sample labels (LIMS), batch record release, and document issuance. Strong communication skills to establish ... How will you make an impact? Supports St. Louis site with tasks like issuing batch records and related documents for biologics manufacturing. What you will do: +… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. + Assist with performing record... lead meetings to develop, implement, and/or update Batch Records , Material Specifications, Forms, Work Practices,… more
- Library of Congress (Washington, DC)
- …selecting from a pick list and links the barcode on the deposit to the record . Determines if the service request contains one or more checks, money orders, or ... After processing 40 checks, batches the checks, generates a batch report, reviews the number and amount of checks,...link items received independently to an ongoing service request record . Searches may also require the use of other… more
- Amgen (Holly Springs, NC)
- …most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional ... to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class...carbon-neutral company by 2027. **Principal Engineer: Facilities / Utilities Lead ** **Live!** **What you will do** Let's do this.… more
- ADM (Kennesaw, GA)
- …document activities including, but not limited, issuing master manufacturing records , review and approving batch records and work insturctions, ensuring ... **90269BR** **Job Title:** Lead QA Tech - Kennesaw, GA **Department/Function:** Operations:...differentials, glass and brittle plastic, EMP, quarantine audits. + Record and evaluate test data, alerting Quality Manager to… more
- Lilly (Concord, NC)
- …site procedures. + Review and approve GMP documentation such as electronic batch records , logbooks, etc. + Support creation of Standard Operating Procedures ... inspection + Previous experience with Manufacturing Execution Systems (MES) or electronic batch records + Previous technical writing experience + Technical… more
