- Merck & Co. (Rahway, NJ)
- …development, and seamless technology transfer to commercial sites.The SSO Operations Specialist will provide hands on assistance for daily production activities ... This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this… more
- Eisai, Inc (Raleigh, NC)
- …across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, accuracy, and compliance with ... accordance with internal standards.Support approval and issuance of Master Batch Records (MBRs)Assist with entering events, change...applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing, auditing, … more
- Aequor (Hicksville, OH)
- …component number. Reviews batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming batches. Sets up ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring… more
- Aequor (Thousand Oaks, CA)
- …to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. Identifying improvement opportunities within the ... work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records , while recording production data and information in a ... in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist , Sun-Wed 2nd Shift as part of the Technical Operations team based… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing ... Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic… more
- Mallinckrodt (Dublin, CA)
- …at all times. *Responsible for completion of tasks according to SOPs and Production batch records (PBR's) *Participate on project teams both above site and ... Job Title Senior Operations Specialist - (Day shift Monday to Friday) Requisition...operations. *Drafting and updating of area SOPs, WI and batch records . *Drive the training of colleagues… more
- Abeona Therapeutics Inc (Cleveland, OH)
- …quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing ... and protocols. Reconcile issued controlled forms, logbooks, notebooks, master production records , and protocols. Review batch -related documentation and ensure… more
- Moderna, Inc. (Norwood, MA)
- …of Quality Systems including CAPAs, deviations, investigations, change controls, SOP review, & batch record review; and Equipment & Process Validation. Apply at ... Preventive Actions (CAPAs). Conduct document revisions and/or document management including batch production records and manufacturing procedures. Participate in… more
- Omni Inclusive (Summit, NJ)
- …regulations. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: *Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and ... with manager and be available onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation… more
- Katalyst HealthCares and Life Sciences (Raritan, NJ)
- …preferred. Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols. Experience with ... TrackWise, CMMS and Maximo Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing… more
- City of Perrysburg, OH (Perrysburg, OH)
- …Duties: Under the general direction of the Income Tax Commissioner, the Tax Specialist performs tasks necessary to assist with income tax collection and to process ... prepares tax returns, assists with delinquency programs, processing of payments, daily batch entry, collections, and other special projects as assigned. Example of… more
- Katalyst HealthCares and Life Sciences (Tampa, FL)
- Job Description: Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with cGMP guidelines. This will ... operations by complying with company and FDA cGMP requirements. Responsibilities: Follow the batch record instructions in the execution of manual process for… more
- eTeam, Inc. (Tampa, FL)
- …or wrapping containers. 1-3 Years Experience Summary: Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in ... the corresponding Room Sanitizations per Departments procedures. Key Accountabilities: *Follow batch record instructions in the execution of manual process… more
- TalentBurst, Inc. (Tampa, FL)
- …3:30pm Mon-Fri Duration: 12 months Job Description: Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in ... tying, packing, or wrapping containers. 1-3 Years Experience Key Accountabilities Follow batch record instructions in the execution of manual process for… more
- APLA Health (Los Angeles, CA)
- …and spent by clinic in conjunction with the Finance department: Batch reconciliation for payments received Resolve billing inquiries/discrepancies with the Billing ... (eg interpreter services, transportation). Work with the transitions of care specialist to coordinate ED/ER follow up patient appointments. Work in conjunction… more
- BioSpace (Concord, NC)
- …with site procedures. *Review and approve GMP documentation such as electronic batch records , logbooks, etc. *Support creation of Standard Operating Procedures ... inspection Previous experience with Manufacturing Execution Systems (MES) or electronic batch records Previous technical writing experience Technical aptitude… more
- Tenthpin (Atlanta, GA)
- …A proven track record in a 'Big 4', Major 'SI', or specialist SAP Consulting Firm would be preferred. Experience in Life Sciences, or process manufacturing ... SAP PP-PI Provide strategic guidance on best practices in production planning, batch management, and shop floor execution to optimize resource utilisation and… more
- Actalent (Bridgeton, MO)
- …standards of quality and accountability. Responsibilities + Review and understand batch records , manufacturing protocols, and registration/clinical batch ... Skills + Quality assurance experience with a focus on batch record review and GMP compliance. +...in a QA role, specifically in document review of Batch Records , Equipment Records , Validation… more
- ThermoFisher Scientific (Greenville, NC)
- …to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous improvement ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
