- 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
- Cipla (Fall River, MA)
- …cleaning and sanitation of production area and machinery as per respective SOP during batch to batch and product to product changeover. Daily monitoring and ... materials and production lines. Conducting process checks and recording in batch manufacturing record. Controlling machine operations with minimum rejections and… 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 (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
- AUROBINDO (Durham, NC)
- …in.Job OverviewEngineering /Manufacturing Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing ... machinery.Perform verifications using special instruments (Caliper, Balance, etc.).Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and… 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
- 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
- Cipla (Fall River, MA)
- …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
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
- Aequor (Thousand Oaks, CA)
- …The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and ... use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality… more
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
- Cipla (Fall River, MA)
- …maintaining quality standard within standard norms. Cleaning machines and area as per batch to batch and product to product change over. Performing operations ... and preventative maintenance of machines. Identifying and assisting in the corrective actions of packaging related issues. Correcting status labelling at all stages of packing line with signature. Ensuring that appropriate equipment calibrations are performed,… more
- Cipla (Fall River, MA)
- …Control Room. Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS ... GDP. Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …system usage.Manage the periodic review process for procedures.Issuance of batch related documentation in support of GMP manufacturing.Reconcile GMP documentation ... of GMP logbooks.Responsible for storage and archival of GMP documents and batch related records.Perform tasks in a manner consistent with the safety policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP ... investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.Work… more
- Aequor (Tampa, FL)
- …or wrapping containers. 1-3 Years ExperienceSummary:Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance ... include the corresponding Room Sanitizations per Departments procedures.Key Accountabilities:Follow batch record instructions in the execution of manual process for… more
- Aequor (Northborough, MA)
- …Good Manufacturing Practices and Safety policies/procedures. Document production activities in batch records, log sheets, attachments and/or electronic Batch ... Records. Maintain sufficient inventory of packaging materials. Follow operational procedures and both written and verbal instructions from the supervisor/Manager. Perform manual packaging on an assembly line. Ability to lift up to 35 lbs. and move heavy… more
- Cipla (Fall River, MA)
- …validation documents of equipment and computer system. Preparation and qualification of e- batch record & e-Log Book. Knowledge of cleaning validation and process ... cGMP records and SOPs. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Hands-on experience facilitating problem solving… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols.Experience with BAS, EMS, TrackWise, ... CMMS and Maximo.Familiarity with IT application design and deployment.Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).#Li-OnsiteBenefitsWe are committed to creating a workplace where employees can thrive - both… more
