- Merck & Co. (Rahway, NJ)
- …guidance. Review and approve GxP documentation including but not limited to batch records , specification, equipment qualifications, change records and ... the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.The Oral Solids Dosage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …lifecycle requirements.Create and issue GMP logbooks.Responsible for storage and archival of GMP documents and batch related records .Perform tasks in a ... with workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …standards, industry standards, and global regulations.Provide Quality Oversight for batch records , change controls, SOPs, non-conformances, risk assessments, ... plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities… more
- Lilly (Branchburg, NJ)
- …Excursions, specifications and Work Orders for compliance to regulatory standards. + Review /approve executed batch records and participate in API ... cross-functional groups with troubleshooting investigations and problem resolution. Reviews batch records /manufacturing documentation and resolves comments to… more
- J&J Family of Companies (Raritan, NJ)
- …techniques. * Perform process unit operations according to standard operating procedures and batch records , and record production data and information in ... Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc.) EDUCATION AND EXPERIENCE:... Review and provide feedback for SOP and Batch Record Revisions REASONING ABILITY: + Interpret… more
- Merck (Rahway, NJ)
- … Review and approve GxP documentation including but not limited to batch records , specification, equipment qualifications, change records and deviations. ... the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division. The Oral Solids Dosage… more
- Catalent Pharma Solutions (Somerset, NJ)
- …equipment. All responsibilities are dictated by strict regulations, eg, cGMPs, SOPs, and batch records . This is first shift position, 7:00AM - 3:30PM, Monday ... production + Accurately complete all applicable documentation pertaining to daily tasks ( Batch Records , Logbooks, Protocols, etc.) + Cooperate seamlessly with… more
- Bristol Myers Squibb (Summit, NJ)
- …manufacturing records and procedures including SOPs and Work Instructions. Associates will review manufacturing batch records and any/all records ... is to collect information from triage and initiate the record in the Quality Management System (QMS) with the...and closure of actions. Associates will write, revise, and review all related GMP documentation for S12… more
- Astrix Technology (New Brunswick, NJ)
- …+ Prepare solutions and buffers for manufacturing processes. + Follow SOPs and master batch records in line with GMP guidelines. + Maintain a ... CAPAs. + Perform daily visual and physical checks, including equipment calibrations. + Review and document data with accuracy. + Independently set up and execute… more
