- 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
- Novo Nordisk (Clayton, NC)
- …+ Perform routine cleaning and good housekeeping as needed for assigned areas + Review electronic batch records real-time to ensure compliance to Standard ... storage & process waste systems preferred + Ability to work with electronic batch records , automated process equipment, and/or DeltaV or Syncade preferred +… more
- Fujifilm (Holly Springs, NC)
- …and preventive action (CAPA) in response to process deviations + Supports generation and review of master batch records (MBRs) and sample plans, as ... analytics, including but not limited to closing deviations, generating master batch records , and data system improvement initiatives. **Company Overview**… more
- Novo Nordisk (Clayton, NC)
- …product quality + Review SOP's & other documents, as required + Real-time review of electronic batch records ensuring compliance to Standard Operating ... Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards + Manage individual training plan + Participate in qualification & validation activities as required + Setup, operate, monitor, & control highly automated processes & systems + Load &… more
- Fujifilm (Research Triangle Park, NC)
- … + Performs pre-production activities, including review and approval of Master Batch Records (MBR), Batch Material Masters (BMM) in SAP, Sampling ... site. This role organizes, maintains, and communicates the status of batch disposition details, and partners cross-functionally, including with external stakeholders… more