- Lilly (Durham, NC)
- …the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, semi-finished devices, ... better for people around the world. The Quality Assurance Batch Disposition team assures patients worldwide of safe and...and final packaged product. + Performs final batch disposition of raw materials, components, active pharmaceutical ingredient… more
- ThermoFisher Scientific (Greenville, NC)
- …development to commercialization. **POSITION SUMMARY** The Quality Assurance (QA) Supervisor, Batch Release oversees QA activities and programs such as auditing, ... record review, final product functions, document management, complaints, oversight...+ Familiarity with concepts, practices, and procedures related to Batch Release activities. + Ability to manage and lead… 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …own batch record cycle completion tracking and adherence. + Request batch records in advance to plan for operational schedule needs. + Coordinate ... completion and delivery of completed batch records to IPQA and Batch Record review. + Facilitate proper GDP batch record corrections are… more
- Fujifilm (Holly Springs, NC)
- … release activities for production including, but not limited to, review of batch records , analytical data, certificates of analysis, and other documents. Acts ... supporting all material and product disposition including drug substance manufacturing, labeling, batch record review, and lot Disposition * Provides status… more
- Mallinckrodt Pharmaceuticals (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
- Herbalife (Winston Salem, NC)
- …with the Agile PLM system. + Generates manufacturing and packaging master batch records in the Electronic Batch Record (EBR) system. + Adhere to ... raw materials in conjunction with the generation of master batch records . Duties will be performed at...and product performance test on finished products, as directed. Record and publish results. + Collect data and communicate… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …manufacturing processing equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing ... required by production leadership. + Review and correction of area specific executed batch records and log books to meet timely closure of the documents. +… more
- Pfizer (Sanford, NC)
- …skids and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations. + **Point of Contact for** the execution ... and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations. + **Point of Contact** **for** the execution and issue… more
- Lilly (Durham, NC)
- …Delivery** + Provide technical oversight to development and deployment of MES Electronic Batch Record (EBR) and ancillary electronic tickets to new drug product ... system for automated material movement. + Lead migration of Electronic Batch Record (EBR) and ancillary electronic tickets for existing manufacturing lines from… more