- Curia (Albuquerque, NM)
- …of operations including in-process inspection, final product inspection, in-process (real-time) batch record review , routine operations quality support ... documents and records , such as SOPs, Master Batch Records , Master Packaging Records ,... activities + Ensure effective in-process (real-time) and final batch record review processes support… more
- J&J Family of Companies (Athens, GA)
- …improvement efforts. **Key Responsibilities:** + Batch Record Review /Auditing: Ensures accuracy and compliance of manufacturing records . Verifying data ... providing quality, compliance, and technical feedback/ regarding quality and manufacturing activities, batch record review and approval, and Quality… more
- Fujifilm (Thousand Oaks, CA)
- …forms management, planner entry form issuance and other tasks + Independently support manufacturing batch record review + Assists in the development of ... and train staff as needed + Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols +… more
- Fujifilm (Holly Springs, NC)
- …Actions Preventative Actions within Trackwise * Leads continuous improvement initiatives * Manages batch record review and cycle time Key Performance ... batch records in electronicsystems managing the production scheduler, batch record reviewers, manufacturing execution systems associates, and training… more
- PCI Pharma Services (Madison, WI)
- …bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable. + Experience performing ... while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining … more
- Bristol Myers Squibb (Summit, NJ)
- …their WCT members. + Performs batch record reviews (BRR) or Electronic Batch Record review by exception. + Ensures that all documentation produced by ... from GMP tasks if observed to not comply with SOPs, Work Instructions, or batch records , including safety trainings. Team Building and Development: + Is… more
- Insight Global (Grand Rapids, MI)
- …position are: Support, review /pre- review , and/or approve the following - - Batch record review -Quarantine shipment (Q-ship) activities -Release for ... 1 Requirement Knowledge Expertise handling review and approval of batch record review , RFFP activities, CAPAs, Change Controls, deviations, quality… more
- Bristol Myers Squibb (Devens, MA)
- …procedures, and quality principles. + Prior experience with quality processes, including batch record review , material disposition, change control, product ... with area owners. + Identify and propose improvements to programs, procedures, and practices. + Review manufacturing batch records or QC testing records … more
- Merck (Durham, NC)
- …compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site ... Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams...+ Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES), Trackwise and GLIMS. +… more
- Actalent (Waunakee, WI)
- …compiling data, and coordinating training activities. Responsibilities + Ensure proper documentation and review batch records . + Inspect and approve raw ... Assurance Specialist is responsible for ensuring proper documentation, reviewing batch records , inspecting and approving raw materials,...with FDA regulations and GMP/ISO standards. + Proficiency in batch record review and document… more