- Legend Biotech USA, Inc. (Raritan, NJ)
- …of 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...the cGMPs and SOPs on daily basisEnsure documents like batch records , labels, forms, etc. are printed… more
- Cipla (Fall River, MA)
- …(eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Conduct room and equipment checks (where ... during batch process and accountability in the batch record . Monitor facility and product environmental... records and contractor related functions. Assess online batch records in terms of completeness of… more
- Cipla (Fall River, MA)
- …materials and production lines. Conducting process checks and recording in batch manufacturing record . Controlling machine operations with minimum rejections ... maintenance and calibration. Manufacturing and filling of products as per Batch Manufacturing Records and SOP. Maintaining inventory of machine parts, tools and… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment ... assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.Utilizes tools within… more
- Cipla (Fall River, MA)
- …are not limited to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master ... batch records . Develops appropriate disposition metrics, works...and SOP's. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Closure… more
- Aequor (Thousand Oaks, CA)
- …training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during ... and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and… more
- Cipla (Fall River, MA)
- …Control Room. Receive approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications, training ... ensuring GDP. Issue the approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications, training … 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 ... signature. Ensuring that appropriate equipment calibrations are performed, and records are maintained. Ensuring line clearance before initiating packaging activities… 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 ... signature. Ensuring that appropriate equipment calibrations are performed, and records are maintained. Ensuring line clearance before initiating packaging activities… 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 ... signature. Ensuring that appropriate equipment calibrations are performed, and records are maintained. Ensuring line clearance before initiating packaging activities… 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 ... investigations, create/revise operational procedures, including manufacturing work instructions, master batch records , forms, and support and manage change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and issuance of GMP logbooks.Responsible for storage and archival of GMP documents and batch related records .Perform tasks in a manner consistent with the safety ... system usage.Manage the periodic review process for procedures.Issuance of batch related documentation in support of GMP manufacturing.Reconcile GMP documentation… more
- Cipla (Fall River, MA)
- …and validation documents of equipment and computer system. Preparation and qualification of e- batch record & e-Log Book. Knowledge of cleaning validation and ... records and SOPs. Knowledge of GDP. Creation and maintenance of batch record and cGMP documentation templates. Hands-on experience facilitating problem… more
- Formation Bio (New York, NY)
- …Lead the quality review process, ensuring the effective review and approval of batch records , release testing, and other quality-related documentation. Foster a ... implementation, and upkeep of quality systems and procedures, including SOPs, batch records , and quality metrics.standard operating procedures (SOPs) pertaining… more
- Aequor (Tampa, FL)
- …packing, or wrapping containers. 1-3 Years ExperienceSummary:Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in ... will include the corresponding Room Sanitizations per Departments procedures.Key Accountabilities:Follow batch record instructions in the execution of manual… more
- Merck & Co. (Rahway, NJ)
- …GxP automation systems.Lead integration of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity ... industry standards.Commissioning and qualification test protocol development and execution-Track record of working effectively with team-members of diverse skill… 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
