- Merck & Co. (Rahway, NJ)
- …This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this ... in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge… 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
- Merck & Co. (Rahway, NJ)
- …This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this ... in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge… 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 ... lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all… more
- Twist BioScience (South San Francisco, CA)
- …of existing MES functionalities, identify opportunities for process automation, electronic batch record optimization, and advanced data utilization. Ensure ... IQ, OQ, PQ protocols and documentation, specifically tailored for custom software.Electronic Batch Record (EBR) Management: Lead the design, development, and… more
- Aequor (Houston, TX)
- …and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) o Problem solving in a cross-functional setting, and participation ... on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for...to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) Computer Skills Proficient in the… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.Experience with mathematical ... and controlExperience with state-of-the-art cell culture processes including intensified inoculum/fed- batch and perfusion process development.Background in data science approaches… 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
- Merck & Co. (Rahway, NJ)
- …semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Interface with key stakeholders within the design team, molding team,… more
- Merck & Co. (Rahway, NJ)
- …and subject matter expertise in cell-culture process development for biologics, fed- batch cell culture, bioreactor scale-up and scale-down, as well as recent ... analysis, and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a history of… more
- AUROBINDO (Durham, NC)
- …printed packaging material as per SOP and according to Packaging Batch Record .Write and revised applicable standard operating procedures(SOPs).Prepare shipping ... in movement of the material to sampling team and dispensing team.Maintain record keeping of all material movement within the warehouse.Inspection and loading of… 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 ... levels of management as appropriate. Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must… more
- Merck & Co. (Rahway, NJ)
- …and subject matter expertise in cell-culture process development for biologics, fed- batch cell culture, bioreactors across scales, as well as recent advances, ... analysis, and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a history of… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… 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 ... we will consider for employment qualified applicants with arrest and conviction records .The base cash compensation for this California-based role is below. In… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …leadership during Agency Inspections, filing of Submissions, and IRs.Maintain global master batch record and documentation on the platform process description ... and analytical methods at both internal and external CMO sitesEnsure global records are consistent and maintained to achieve consistent performance worldwide for… more
- Merck & Co. (Durham, NC)
- …Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic ... Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance… more
- Repligen (Hopkinton, IA)
- …and file records appropriately.Process requests and generates labels and batch records for production.Documentation Archival, on and off-site.Assist and ... and electronic).Maintains related database systems, if applicable, logs and complete forms/ records as required.Adheres to written policies and procedures related to… 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 ... with physical dexterity sufficient to use computers and document production records .Ability to handle human derived materials in BSL-2 cleanroom facility.Physical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process ... as a Site MES SME to support Quality Investigations, Corrections, and QMS records .Build the Site Readiness of MES for FDA and/or Other Regulatory Audits /… more
