- 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 (Hauppauge, NY)
- …logged, timestamped, and attributed to the correct users. Ensure that all changes to batch records are valid and consistent with the intended production process. ... escalate as needed. Review user activity logs within the batch record systems to ensure compliance with...access are appropriately documented and validated. Ensure that all batch records and associated audit trails comply… more
- Cipla (Central Islip, NY)
- …in accordance 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... Review and Release Contributes to process improvement of batch records and associated processes (eg turnaround… more
- Merck & Co. (Durham, NC)
- …of operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as ... issues with product accountability and SAP system discrepancies. - Executes real-time batch record review and ensures timely closure of shopfloor order.--… 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
- 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 (Reid, WI)
- …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
- 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
- Repligen (Clifton Park, NY)
- …silicone, plastic components, and tubing according to work instructions, batch records , and quality standards.Perform inspection of components ... and document packaged components accurately, ensuring compliance with traceability and batch record requirements.Follow standard operating procedures (SOPs) and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various ... packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the packaging… more
- Endo International (Raleigh, NC)
- …to manufacturing responsibilities. This includes understanding and following all applicable batch records , standard operating procedures and work instructions, ... boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records , procedures, and good documentation practices. + Operates and… more
- Twist BioScience (South San Francisco, CA)
- …and organized, have the ability to follow established SOPs and complete manufacturing batch records to contribute to the daily production schedule. The ideal ... and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will… more
- Curia (Albuquerque, NM)
- …and approving regulated documents and records , such as SOPs, Master Batch Records , Master Packaging Records , Protocols, Reports, Deviations, CAPAs, ... of operations including in-process inspection, final product inspection, in-process (real-time) batch record review, routine operations quality support including… 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
- 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 ... and update SOP's of medium level of complexity. 3. Reviews new and/or updated batch records . Line Schedule Adhered to A. Is at his/her position on the line ready… 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
- Cipla (Fall River, MA)
- …are not limited to the following : Review of batch manufacturing/packaging record . Review of engineering records such as temperature and humidity data ... calibration and PM records , pest control records and contractor related...of all the equipment and associated controls during the batch run. Act as quality lead for all shop… 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
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