- ThermoFisher Scientific (Millersburg, PA)
- …+ Collaborate with other site functions to drive processes and resolve issues + Perform Batch Record /Document Review + Review & Revise SOPs/Quality ... **What will you do?** + Direct the daily workload to ensure batch review timelines are achieved while managing available resources and maintaining cGMP quality… more
- Nitto Denko Corp. (Milford, MA)
- …with QA Systems to support trending and KPI reporting related to raw material and batch record review cycle times. Required Skills/Abilities: + The job ... as a lead QA representative for Raw Materials and Batch Records to ensure timely, compliant, and.../ batch records , and raw materials records . + Review and verify raw material… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …completion and delivery of completed batch records to IPQA and Batch Record review . + Facilitate proper GDP batch record corrections ... Operations BPR Lead is responsible for the real time batch record review program in...record cycle completion tracking and adherence. + Request batch records in advance to plan for… more
- Novo Nordisk (Bloomington, IN)
- …IT related issues, and offers suggestions for new/improved equipment + Assist QA Batch Record Review with Client Observations, including priority ... Associate + Review and Approve new client batch records + Create, review ,...BRs during Analyst review + Assists QA Batch Record Review with Client… more
- Novo Nordisk (Bloomington, IN)
- …+ Assist with revision of GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMPs + Initiate deviations as required ... Perform audits of manufacturing and support areas, including in-process batch record review for adherence...and approval of project related documents such as Master Batch Production Records , technical transfer, and process… more
- Curia (Albuquerque, NM)
- …primary quality assurance contact for CURIA-Albuquerque clients + Responsible for ensuring batch records have been thoroughly reviewed before product disposition ... improvement initiatives + Will provide quality training related to batch review , sitewide + Read/interpret SOPs to...pressure to meet customer and business deadlines associated with batch record lot release Other Qualifications: +… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. + Assist with performing record...information. + Assist in the preparation of annual product review data. + Assist with generating and presenting quality-related… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is ... adhered to. Job Description ESSENTIAL FUNCTIONS : + Execute batch record review and document...complex calculations and formulas + Ability to focus and review batch records for an… more
- Fujifilm (Holly Springs, NC)
- …supporting all material and product disposition including drug substance manufacturing, labeling, batch record review , and lot Disposition * Provides ... batch release activities for production including, but not limited to, review of batch records , analytical data, certificates of analysis, and other… more
- Boehringer Ingelheim (Fremont, CA)
- …The Specialist trains junior modelers to learn how to generate batch records , generates and refines batch record creation training materials, and ... records in BioMES. Leads team to create new batch record types and systematically evaluate information...business process owner for BioMES business processes such as batch record templates, review processes,… more