- Actalent (Kalamazoo, MI)
- Job Title: Batch Record Review Specialist...and cGMP standards. You will create, edit, and proofread batch records and product labels while checking ... Job Description The Batch Record Review Specialist will be responsible for reviewing tickets in...policies and cGMP standards. + Create, edit, and proofread batch records and product labels. + Identify… 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
- Lilly (Durham, NC)
- …product released to the market meets applicable GMP standards. **Responsibilities:** + Review related batch records associated with parenteral manufacture, ... to make life better for people around the world. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device… more
- Novo Nordisk (Bloomington, IN)
- …on the floor + Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good ... logbooks and resolving issues that occur during manufacturing + Review batch documents + Review ... Review /Disposition (DP and DS) + Reviews executed batch records + Dispositions product with delegation… 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)
- …+ 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