- Merck & Co. (Rahway, NJ)
- …of this position as it will be based on the shop-floor. Experience with electronic batch records and documentation is a plus.This position is 100% on-site and ... responder and early troubleshootingCoordinates with Mechanical team for area/equipment availabilityPost-reviews batch records and cleaning records for GDP… 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 ... to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to...logbooks.Responsible for storage and archival of GMP documents and batch related records .Perform tasks in a manner… more
- Merck & Co. (Durham, NC)
- …external regulatory inspections, presenting on topics as needed. Executes and manages Operations batch record review within established timelines for release ... operation Technical writing experience, ie investigations, change requests, standard operating procedures, batch records , protocols. Must be able to work both… more
- Aequor (Thousand Oaks, CA)
- …packaging, and labeling sampling for Biotech/pharma Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to ... printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review . Secondary responsibilities will include… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional ... assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.Utilizes tools within… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures. Gown properly following the standard operational proceduresRecord, maintain and review completed production documentation ( batch records , log ... with the compounding of various commercial and research drug products and formulations.Document batch records with the utmost attention to detail using cGMP… 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 ... to realize your potential? The Position This position will review manufacturing and support documentation and records ...and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and… 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 (Bothell, WA)
- …Summary): The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Emerson Syncade ... development and validation process. Perform and communicate planning, development, peer review , and testing solutions for recipe creation and modification Execute… more
- 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 ... product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists in the… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols.Experience with TrackWise, ... integrityExecutes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentationParticipates in authoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards, industry standards, and global regulations.Provide Quality Oversight for batch records , change controls, SOPs, non-conformances, risk assessments, ... provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. They will be… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Batch Record Reviewer ** **Summary:**...documentation practices (GDP), including but not limited to: executed batch records , master batch ... AAV and other viral vector-based therapies and vaccines._ The ** Batch Record Reviewer ** is responsible...validation protocols and reports and SOPs + Independently executes record review for completeness, accuracy and cGMP… more
- Actalent (Morristown, NJ)
- Urgently hiring a QA Batch Record Reviewer to support...remote (Need to be local to NJ/NY/CT) + Performs batch record review and release for ... a backlog of batch records for a CDMO generic pharmaceuticals. Essential Duties: +...Third party manufactured solid oral dosage products. + Review analytical testing results for solid oral dosage products… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... **Overview:** The Quality Assurance Specialist is responsible for reviewing records to comply with QSR and ISO requirements. They...signing in relevant sections of documents. + Reviewing the batch records online, if necessary. + … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Providing consultation or advice in alignment with QA policies + Reviewing completed records and batch sheets and working with other departments and communicate ... guidance on QA procedures and polices as well as review of documents for both internal and external transfers...Performing activities associated with disposition of product (eg document review , shipping), activities may be on the floor or… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Supervisor Quality Assurance ( Batch Record Review ) position. This position performs activities supporting dispositioning ... associated with disposition of raw materials and product (eg receipt, inspection, document review , shipping, etc.), activities may be on the floor or at a desk… more
- ThermoFisher Scientific (Cincinnati, OH)
- …needs, driving the team's daily work plan to ensure results are met. Lead the batch record disposition team to achieve site goals for delivery and accuracy ... ensuring compliance with all relevant directives and procedures. Compile and review batch release documentation packages to ensure they meet our stringent… more
