- 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
- 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
- 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
- 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …required by production leadership. + Review and correction of area specific executed batch records and log books to meet timely closure of the documents. + ... equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current...Review , correction and close out of area specific batch records . - Maintain documentation and functional… more
- Pfizer (Sanford, NC)
- …skids and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations. + **Point of Contact for** the execution ... Right first time execution and continuous improvement, the timely review of daily documentation and completes data entry; Monitor,...with varying levels of automation. + Follow SOPs and batch records for unit operations. + **Point… more
- Pfizer (Sanford, NC)
- …directly impacts patients. **What You Will Achieve** In this role, you will: + Perform batch record review and final batch disposition for clinical ... products are released in a timely manner + Effectively review /approve GMP documents to ensure quality attributes are met....Quality team and/or the site. + Complete queries for batch data to support regulatory requests. + Contribute to… more
- J&J Family of Companies (Wilson, NC)
- …pharmaceutical water systems and utilities. + Provide documentation support for SOP/WIs/ Batch Record revisions. + Identify necessary document changes and ... group to ensure timely revision to all SOP and batch records . + Create and or provide...and or provide documentation support for SOPs, WIs, and Batch record revisions + Is responsible for… more
- Fujifilm (Holly Springs, NC)
- …role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that ... and manages the QA DSM Operations teams, including the Batch Review and Release teams and the...other GMP functions (manufacturing, MSAT, Engineering) * Strong track record of driving operational excellence * Experience with the… more
- Kelly Services (Winston Salem, NC)
- …and safety standards. + Review and revise GMP documentation such as SOPs, batch records , and forms to ensure compliance and accuracy. + Oversee inventory ... maintaining quality standards. + Revise, update, and ensure adherence to SOPs, batch records , and related forms, maintaining compliance with regulatory… more