- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Batch Record & Document Coordinator as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewThe Batch Record and Documentation Coordinator will work in a...will work in a detail-oriented compliant manner coordinating the batch record flow, correction, proper and complete documentation.Schedule: Sun-Wed… more
- Rogers Corporation (Carol Stream, IL)
- Batch Mixer Location: Carol Stream, IL, US, 60188 Job Category: Operations Shift: Shift 2 Full Time / Part Time: Full-Time Job Level: Individual Contributor ... Approximate Travel: 0% Job Description: **Summary:** The role is responsible for the production of safely, efficiently, and consistently made silicone batches to meet foamline demand. Take direction from the department supervisor on a daily basis. **Essential… more
- Cipla (Hauppauge, NY)
- …timestamped, and attributed to the correct users. Ensure that all changes to batch records are valid and consistent with the intended production process. Investigate ... escalate as needed. Review user activity logs within the batch record systems to ensure compliance with 21 CFR...access are appropriately documented and validated. Ensure that all batch records and associated audit trails comply with 21… more
- Cipla (Central Islip, NY)
- …with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, and product specific ... documents Independently executes batch record review for completeness, accuracy and cGMP compliance....reports and SOPs Compile and report performance metrics for Batch Review and Release Contributes to process improvement of… more
- Merck & Co. (Durham, NC)
- …operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as needed, ... issues with product accountability and SAP system discrepancies. - Executes real-time batch record review and ensures timely closure of shopfloor order.-- Reviews… more
- Cipla (Hauppauge, NY)
- …process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch ... company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper… more
- Cipla (Hauppauge, NY)
- …process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch ... company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper… more
- Cipla (Hauppauge, NY)
- …process. Dispensing printed packaging materials to packaging. Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch ... company policies, safety requirements, cGMP and SOP's. Review of online batch records, area/equipment logbooks, calibration/PMP records etc. Ensure the proper… more
- Cipla (Fall River, MA)
- …weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where applicable) ... Ensure the proper isolation of rejected material generated during batch process and accountability in the batch ...during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.… more
- Cipla (Reid, WI)
- …Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation Specialist ... not limited to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master batch… more
- Repligen (Clifton Park, NY)
- …silicone, plastic components, and tubing according to work instructions, batch records, and quality standards.Perform inspection of components for defects, ... document packaged components accurately, ensuring compliance with traceability and batch record requirements.Follow standard operating procedures (SOPs) and maintain… more
- Endo International (Raleigh, NC)
- …manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and ... indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices. + Operates and monitors… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment to… more
- Kerry (Bethlehem, PA)
- …The successful candidate will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that all processes meet ... ensure sanitary conditions of all equipment. + Accurately enter batch data and monitor production workflows using SAP and...data and monitor production workflows using SAP and physical batch records. + Verify batch integrity and… more
- Kerry (Bethlehem, PA)
- …The successful candidate will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that all processes meet ... ensure sanitary conditions of all equipment. + Accurately enter batch data and monitor production workflows using SAP and...data and monitor production workflows using SAP and physical batch records. + Verify batch integrity and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging ... of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the packaging process… more
- Twist BioScience (South San Francisco, CA)
- …organized, have the ability to follow established SOPs and complete manufacturing batch records to contribute to the daily production schedule. The ideal candidate ... and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will… more
- Endo International (Hobart, NY)
- …accurate and compliant documentation on all activities. **Job Description** Essential Functions Batch Record Executed A. Sets up and operates equipment in blending ... state of safety and cleanliness. E. Stages materials needed to produce the batch . F. Blends ingredients using appropriate process, time intervals and equipment. G.… more
- Greene Tweed (Kulpsville, PA)
- …tasks in compliance with ISO/IEC 17025 and standard procedures. - Performs batch approval testing for elastomer compounds and plastics. Demonstrates the following ... Elastomer/Thermoplastics Specifications. Generates, reviews, and modifies elastomer and thermoplastic batch reports. - Uses current elastomer and thermoplastics SAP… more
- Integra LifeSciences (Plainsboro, NJ)
- …around start/stop, breaks and timely completion of tasks **Paperwork** + Obtain batch records in advance for associated manufacturing operations to prevent delays + ... keep manufacturing operations on track and progressive + Provide comments in batch records not limited to non-conformance references or other clarifications +… more
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