- Sumitomo Pharma (Morrisville, NC)
- …product manufacturing and aseptic techniques. + Relevant experience and knowledge of manufacturing, batch record review , and/or analytical analyses for the ... + Responsible for providing QA review /approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the… more
- ThermoFisher Scientific (Greenville, NC)
- …Analysis to support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous ... operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development… more
- Catalent Pharma Solutions (Greenville, NC)
- …targeted drug development. The **Documentation Specialist** provides administrative support for commercial batch record review , EDMS, training modules and ... the electronic Quality Management System (eQMS). **The Role** + Perform review of executed commercial batch records to ensure quality and accuracy + Partner… more
- United Therapeutics (Research Triangle Park, NC)
- …facility, this is the role for you. + Weigh raw materials per Production Batch Record specifications to ensure products are properly formulated + Operate, clean, ... the execution of batches in the production process + Review batch manufacturing documentation as well as...batch manufacturing documentation as well as all cleaning records and labels to ensure accuracy and adherence to… more
- Astellas Pharma (Sanford, NC)
- …approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition. + Review and approve Product Specification documents to ... protocols, and reports for Quality and GMP-related functions. + Author, review , and approve Quality System records , including Nonconformances, Corrective… more
- ThermoFisher Scientific (Greenville, NC)
- … Batch Release oversees QA activities and programs such as auditing, record review , final product functions, document management, complaints, oversight of ... goals. + Supervision: Supervise staff performing quality and manufacturing audits, record review , final product release functions, complaints, APR, validation,… more
- Catalent Pharma Solutions (Greenville, NC)
- …preferably with 3 years in a Quality role. + At least 1 year of batch record review and on the floor quality assurance manufacturing support. + Position ... QA Management, supporting and providing guidance to laboratory staff as assigned. + Review Quality documentation including but not limited to review of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products ... and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides… more
- Mentor Technical Group (NC)
- …and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review experience. + Available for non-standard ... shifts which include nights and weekends. + Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS. Education & Qualifications + Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …lab coats, operating and cleaning supplies, etc.) * Prepare annual product reviews. * May review Batch Production Records (BPRs) and SOPs for accuracy. * ... all duties of the Data Analyst I and performs a thorough forecast/analytic review of materials for the production and supplies needed in Manufacturing production to… more
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