- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Merck Group (Indianapolis, IN)
- …in a pharmaceutical or biotech company. Preferred Qualifications: Experience in data analysis, batch record review , deviation investigation, and CAPA project ... metrics, and areas for improvement within the manufacturing systems. Reviewing batch records to support product release, ensuring accuracy, compliance,… more
- MSD (Rockville, MD)
- …materials to ensure quality standards and customer requirements, and document all findings. Review batch records for quality control testing materials and ... receipt and release of materials and maintains complete and precise records to support manufacturing and quality operations. DUTIES AND RESPONSIBILITIES: Confirm… more
- Cedent (Pompano Beach, FL)
- …Receive and qualify incoming materials and reagents according to GMP requirements Review batch records , laboratory notebooks, and QC testing ... skills Effective written and verbal communication skills Ability to review and interpret technical documents and records ...to review and interpret technical documents and records Self-motivated with the ability to work independently and… 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
- Enterprise Management (Baltimore, MD)
- …and other departments to support clinical and administrative needs. 8. Conduct batch documentation audits, including review and signature of referrals, treatment ... providers in cases involving shared clients or complex care needs. 10. Accept and review incoming lab results in ICANotes; use clinical judgment to adjust care plans… more
- Eli Lilly and Company (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
