- 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
- 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
- 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
- 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
- RESILIENCE (West Chester, OH)
- … records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified Provides constructive ... feedback to individuals executing batch records and communicates best practices to...Communicate clearly with cross-functional teams Supports QA processes including batch record review and quality… 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
- IntePros (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... all process equipment are within required specifications. Performs in-line review of batch record (MPI)...when the audit was conducted. Proactively identify gaps in batch records to mitigate deviations and documentation… 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
- 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
- LanceSoft (Boston, MA)
- …strategic plans, knowledge base, error correction strategies and tactical processes through batch log review , consultation with end users and programming and ... assess user needs to determine feasibility of automating solutions to user issues Review changes in State and Federal regulations to determine the impact on existing… more
- Tolmar (Windsor, CO)
- …and qualification of all direct reports before duties are assigned. Ensures the batch record review process, including prioritization and reviewing ... including but not limited to: line orientation and risk review of all new team members or those transferring....prevent recurrences of a non-conformance. Pre-approves expiration dates on batch records prior to start of manufacturing… more
- Actalent (Muskego, WI)
- …SQF, GFSI, and PCQI standards. Food safety expertise. Experience in food manufacturing and batch record review . Additional Skills & Qualifications 2+ years ... that is expanding its operations due to increasing customer demands. Responsibilities Review and approve records to ensure compliance. Identify deviations and… more
- Abeona Therapeutics Inc (Cleveland, OH)
- …of the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing ... and protocols. Reconcile issued controlled forms, logbooks, notebooks, master production records , and protocols. Review batch -related documentation and… more
- Collabera (Thousand Oaks, CA)
- …for training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review , and acting as a QA liaison ... Manufacturing and Facilities & Engineering areas/staff. Purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order… more
- Berry Global, Inc (Baltimore, MD)
- …meet customer specifications and company requirements. Assist with collecting and filing paperwork. Review batch records using JDE to verify lot production ... from managers, clients, customers, associates, and the general public. Track record of continuous quality improvement and goal attainment. Additional Info Pay… more
- Moderna, Inc. (Norwood, MA)
- …Systems including CAPAs, deviations, investigations, change controls, SOP review , & batch record review ; and Equipment & Process Validation. Apply ... Preventive Actions (CAPAs). Conduct document revisions and/or document management including batch production records and manufacturing procedures. Participate in… more
- Legend Biotech US (Somerset, NJ)
- …deviations, change controls, and tech transfers. Support GMP batch release and batch record review activities with quality partners. Collaborate with ... by external partners and implement appropriate controls. Author and review technical documents, protocols, and reports, including regulatory filings. Support… more
- Agilent (Boulder, CO)
- …Process Development. Responsible for writing or reviewing new process documentation (master batch records or data capture forms) and automated equipment methods. ... required to support the scale-up. Responsible for the generation and/or review of batch summaries for all batches produced in the manufacturing facilities.… more
- BioSpace (Lebanon, IN)
- …cross-functional stakeholders. Support authoring and revision of standard operating procedures and batch records as required. Review technical reports. ... chillers, cooling towers, compressed air, distillation, tank transfer operation, batch processes, truck/rail operations) Demonstrated operational capability with high… more
