- Cardinal Health (Indianapolis, IN)
- …+ Maintains accurate and current Quality records + Performs real-time QA review of batch documentation and other GMP related documents. + Issuance and ... other status protected by federal, state or local law._ _To read and review this privacy notice click_ here… more
- Novo Nordisk (Bloomington, IN)
- …to the Manager to be added as required + Review all activities within the Master Batch Record (MBR) throughout the shift, at the end of shift and at the end ... equipment in accordance with cGMPs + General understanding of batch records and following procedures based off...following procedures based off the steps provided in a batch record + Troubleshoot basic equipment and… more
- Lilly (Indianapolis, IN)
- …out in a compliant manner. + Approving specifications, sampling instructions and master batch records . + Ensuring robust control strategies are developed and ... a system to release or reject materials and intermediates. + Ensuring the evaluation of batch production records . + Ensuring all essential testing is carried… more
- Dairy Farmers of America (Richmond, IN)
- …Description** **GENERAL PURPOSE** Review specifications, procedures, protocols, and batch records for Good Manufacturing Procedures (GMPs) compliance to ... regulatory review findings . File and maintain batch production and control records . Inform...and company computer systems . Able to keep good records ( record keeping skill) . Able to… more
- Novo Nordisk (Bloomington, IN)
- …in EDMS + Review Label Control specific activities within the Master Batch Record (MBR) to ensure effective and accurate communication of production ... visual factory + Required to read, understand, follow, and review GMP documents + Leads area continuous improvement activities...+ Reviews all non-equipment specific activities within the Master Batch Record (MBR) throughout the shift to… more
- Lilly (Indianapolis, IN)
- … Review and approve documents such as procedures, production records , change control proposals, deviations, equipment qualifications, analytical methods, and ... Overview:** The QA - API provides support to all quality activities including batch disposition of API batches at Contract Manufacturing organizations (CMs). The QA… more
- Novo Nordisk (Bloomington, IN)
- …Author and/or review documents including but not limited to master batch records , technology transfer plans/reports, protocols, bill of materials, process ... or our clients. It will also involve drafting and review of documentation, compilation, and assessment of process data,...and monitor corrective action + Ability to write SOPs, batch records , and reports with guidance +… more
- Cognizant (Indianapolis, IN)
- …in the Medical Device and pharmaceutical manufacturing industries Understand the paper Batch record and business process flow in collaboration with business ... 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ) Perform IQ (application...designs into OpCenter by looking through existing documentation (paper Batch Records ) **Why Join Us:** + Opportunity… more
- Lilly (Indianapolis, IN)
- …with CMs. Provide on-site support during inspections. + Participate on the Technical Review Board + Evaluate and disposition Dry and packaging Product batches, if ... Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to … more
- Lilly (Indianapolis, IN)
- …Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to ... batch release. + Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control… more