- Aequor (Framingham, MA)
- …manufacturing and support operations to ensure a culture of continuous compliance. Perform batch record review . Perform quality inspections of intermediates ... and finished goods. Perform review of QC data. Perform logbook review . Provide on the floor (OTF) support to the operations department, including OTF support for… 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …corrective and preventive actions including:Provide management oversight for quality control, batch records , and material review board.Provide management ... and oversee the conformance to the QMS through internal audits and management review . In addition, the Quality Director will represent the company as the Quality… 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 ... the organizational chart. Essential Functions Reviews all manufacturing and support records to certify compliance with specifications and procedures Works closely… more
- AUROBINDO (Dayton, OH)
- …of Process Validation batches under Support production in trouble shooting.Preparation of Manufacturing Batch Records , Packaging Batch Records for ... have some experience in development to large scale submission batch manufacture.This is a temporary position.ResponsibilitiesR&D Scientist with previous industrial… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on the manufacturing process and QMS systems Revise and create documentation (SOP, batch records , FT's) associated with the manufacture of product, requiring ... of process and equipment improvement initiatives, reviews completed quality records , generates quality deviation responses, drive investigations and has ability… more
- Merck & Co. (Durham, NC)
- …up 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)
- …preferred.Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols.Experience with ... 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)
- …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
- 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
- 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
- Catalent Pharma Solutions (Harmans, MD)
- …records , product labels, SMPs, and product specific documents. + Independently executes batch record review for completeness, accuracy and cGMP ... **We're hiring Batch Record Reviewers to** **provide documentation...documentation practices (GDP), including but not limited to: executed batch records , master batch … 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
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... be a member of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and… more
- BeiGene (Hopewell, NJ)
- …Responsibilities:** + Supervises direct reports within the Manufacturing QA Team, assist with batch review and release, as necessary. QA, Mfg. shop floor QA ... availability of adequate competent resources to carry out the review and approval of batch documentation and...Quality Operations on the shop floor. + Demonstrable track record and skills/experience gained within a similar position(s), at… more
- Curia (Albuquerque, NM)
- …industries. The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor ... the timely review and disposition of executed batch records (clinical, commercial, and media fills)....responsibilities include supporting the establishment, tracking, and improvement of batch record review and disposition… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- PCI Pharma Services (Philadelphia, PA)
- …individual will contact the appropriate personnel to recalibrate and/or remediate the issue. Review batch record (MPI) to ensure equipment challenges and ... when the audit was conducted. Identify proactively gaps in batch records and PDRs to mitigate deviations...QA inspectors/auditors, batch record preparation, batch record review , document change… more
- Actalent (Mainland, PA)
- … records . + File and archive documentation. Essential Skills + Quality assurance + Batch record review and release + cGMP compliance + Quality control ... + Experience with documentation in a cGMP environment + Familiarity with batch records review and/or release Work Environment The work environment is… more
