- Eisai, Inc (Raleigh, NC)
- …plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review , SOP writing, auditing, batch ... foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness,… more
- Merck & Co. (Rahway, NJ)
- …API are manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records , testing data, and ... independent batch release or reject decisions.-- Conduct independent auditing, review , and approval of diverse and complex document types, as required, including… more
- Aequor (Houston, TX)
- …and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) o Problem solving in a cross-functional setting, and participation ... on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for...to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) Computer Skills Proficient in the… more
- Merck & Co. (Rahway, NJ)
- …semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Interface with key stakeholders within the design team, molding team,… more
- Repligen (Hopkinton, IA)
- …and file records appropriately.Process requests and generates labels and batch records for production.Documentation Archival, on and off-site.Assist and ... timely manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval, ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… more
- Merck & Co. (Durham, NC)
- …all Good Manufacturing Practices (GMPs), safety, and environmental regulations.- Review and approve automation documents, preventive maintenance, and SOPs to ... Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic… more
- Insmed Incorporated (San Diego, CA)
- …participate in the process execution within a Pilot Plant non-GMP manufacturing environment. Review batch records , SOPs, raw material specifications, ... protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert… more
- Eisai, Inc (Exton, PA)
- …and preventive actions.6. Oversee and coordinate the preparation of bill of materials, batch records , SOPs, and close-out reports for Biologics Pilot Plant ... and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's discretion.5. Lead… more
- Actalent (Bridgeton, MO)
- …with regulatory expectations. Essential Skills + Quality assurance experience with a focus on batch record review and GMP compliance. + 2-4 years of ... and maintaining high standards of quality and accountability. Responsibilities + Review and understand batch records , manufacturing protocols,… more
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... to make life better for people around the world. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …slip and other related documents. + Review of Certificate of analysis, Batch records , Certificate of conformance and Investigation reports. + Coordinate with ... Quality Assurance Associate - Batch Release Department: Quality Location: Allentown, PA START...an exhaustive list of all responsibilities and duties. + Review of Data logger communication (DLC) form along with… more
- Lilly (Pleasant Prairie, WI)
- …operations to ensure regulatory approval of the facility. **Responsibilities:** + Performs batch records review for Component Preparation, Formulation, ... the pharmaceutical or medical device industry in QA roles + Previous batch review and disposition experience + Ability to make technical decisions, provide… more
- Traylor Bros., Inc. (Chippewa County, MI)
- Batch Plant Superintendent opportunity with Traylor Bros., Inc.! Traylor Bros., Inc. (TBI) National Heavy Civil division provides comprehensive, cutting-edge heavy ... complex bridge construction and rehabilitation projects across the nation, including world record cable-stayed structures and segmental bridges. The group also has a… more
- ThermoFisher Scientific (Greenville, NC)
- … Batch Release oversees QA activities and programs such as auditing, record review , final product functions, document management, complaints, oversight of ... goals. + Supervision: Supervise staff performing quality and manufacturing audits, record review , final product release functions, complaints, APR, validation,… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Perform quality batch record review + Aid in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- The Estee Lauder Companies (Melville, NY)
- …The Compounder Helper/ Batch Reviewer 's primary responsibility concerns manufacturing batch record control and review . This includes collection, ... versus Company requirements and needs.⁃ SOP/OPS/WKI creation, modification and management.⁃ Perform review of executed batch records .⁃ Scan and file… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …completion and delivery of completed batch records to IPQA and Batch Record review . + Facilitate proper GDP batch record corrections ... Operations BPR Lead is responsible for the real time batch record review program in...record cycle completion tracking and adherence. + Request batch records in advance to plan for… more
- Boehringer Ingelheim (Fremont, CA)
- …The Specialist trains junior modelers to learn how to generate batch records , generates and refines batch record creation training materials, and ... records in BioMES. Leads team to create new batch record types and systematically evaluate information...business process owner for BioMES business processes such as batch record templates, review processes,… more
