- 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 (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
- 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
- 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
- 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
- Thermo Fisher Scientific (Greenville, NC)
- … Batch Release oversees QA activities and programs such as auditing, record review , final product functions, document management, complaints, oversight of ... organizational goals. Supervision: Supervise staff performing quality and manufacturing audits, record review , final product release functions, complaints, APR,… more
- Cipla (Fall River, MA)
- …batch record . Monitor facility and product environmental operating conditions. Review of engineering records such as temperature and humidity data ... (eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where… more
- BioSpace (Norwood, MA)
- …and training support. The MA II is accountable for the accuracy of SOPs, MES/paper batch records , and for owning quality system records tied to their ... component prep, formulation, inspection, and packaging. Ensure SOPs and batch records (paper and MES) are accurate,...change controls associated with manufacturing operations. 5. MES & Batch Record Integration Collaborate with the MES… more
- Actalent (North Billerica, MA)
- …working with contract manufacturing organizations (CMOs). Experience in quality assurance, batch record review , and deviation management. Knowledge ... and quality investigations. Responsibilities Review quality management systems and batch records . Conduct investigations and manage CAPAs and change… more
- QPS Employment Group (Rockford, IL)
- …and equipment calibration dates on all process equipment are within required specifications - Review batch record to ensure equipment challenges and hourly ... the audit was conducted - Identify proactively gaps in batch records and to mitigate deviations and...errors - Participate on improvement teams (ie, FMEA's, Kaizen, batch record etc.) as needed - Support… more
- Alkermes (Waltham, MA)
- …instrument and method qualifications Stability protocols and data Master and executed batch records Cleaning verification protocols Quality risk assessments SOPs ... disposition. Compile deviations, change controls, analytical data and batch production record reports to support ...to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation… more
- MannKind Corporation (Danbury, CT)
- …Kitting equipment / Process Point of contact on the manufacturing floor as needed Review Master Batch Records for compliance, identify issues, and suggest ... possible resolutions. Review executed batch records -... records Perform QA activities in the batch record . Perform QC/Retain sampling for each… more
- City of Rancho Palos Verdes, CA (Rancho Palos Verdes, CA)
- … changes and resolves differences; maintains the accuracy of accounting and financial records . Processes payments in batches and logs batch reports as ... position will be open until filled with a first review of applications on June 9, 2025 Why Rancho...adjusting, and maintaining manual and computerized account and financial records according to established policies and procedures. Verifies, posts,… more
- Sprague Pest Solutions (Montclair, CA)
- …and scheduling. Handle incoming service requests via phone, email, or online portal. Review daily reports, batch tickets, and ensure quality control. Account & ... quality check technician reports and paperwork, resolve and escalate issues, and file records accurately. Review call backs and after hours calls from clients;… more
- Vetio (Jupiter, FL)
- …holding of dietary supplements. This role manages day-to-day quality operations, including batch record review , deviation investigations, internal audits, ... per 21 CFR Part 111 and 21 CFR 507. Review and approve Master Manufacturing Records (MMRs)...GMPs, especially Subparts E, F, G, H. Experience with batch record review , CAPA systems,… more
- Cellipont Bioservices (Spring, TX)
- …occur during manufacturing. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures ... and industry best practices. Review and dispositions executed batch ...of Microsoft Office and database management skills, organization, and record keeping skills required. Clear problem-solving and decision-making skills… more
- Philadelphia Hand to Shoulder Center (Glen Mills, PA)
- …in a timely manner. Maintains general knowledge of insurance plans accepted by Premier. Records all record requests in the system and reviews HIPAA requirements ... and patient Medical Record Request form prior to the release of patient...cash drawer, daily balances the cash drawer, and closing batch . Protects patients' rights by maintaining the confidentiality of… more
