- 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
- Formation Bio (New York, NY)
- …the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation. Foster a culture ... implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and quality metrics.standard operating procedures (SOPs) pertaining to… more
- Merck & Co. (Rahway, NJ)
- …independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities ... clinical supplies.- Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval,… 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
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