- Sanofi Group (Swiftwater, PA)
- …with regulatory requirements and company standards + Overseeing review and approval of batch records and associated documentation + Ensuring all batch ... a matrix environment highly preferred + Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …Document Control role is responsible for preparing customer files, reviewing and approving batch records , and releasing finished products while serving as the ... shipping, and quality groups to ensure timely and compliant batch record review and release. It's an...a global setting. **The Role** + Review and approve batch records before production to ensure compliance… more
- PCI Pharma Services (Philadelphia, PA)
- …and Use Begin forms prior to start-up. + Checks all incoming components against the batch record to verify that they are correct. + Documents receipts in the ... batch record . + Fills out In-Process and... batch record . + Fills out In-Process and Reject labels prior...all line personnel sign the required sections of the batch record and training sheets, and initial… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …monitoring and supervising clinical production staff within a specific clinical packaging batch record operation. This position requires a general knowledge of ... and OSHA rules and regulations in the specific production batch record assigned + Oversees specific ...room operation + Responsible for entering data accurately in batch records and logbooks + Must review… more
- Merck (West Point, PA)
- …the PAMS Project Manager will design, configure, validate, and support electronic batch records (EBRs) and manufacturing execution workflows using PAS-X and ... planning, delivery and sustainment for MES/EBR (Manufacturing Execution System/Electronic Batch Record ) initiatives. This role requires intense collaboration… more
- Bayer (Saxonburg, PA)
- …of these records to assure that a complete device history record is available. Review batch packets for sub-assembly, pre-sterile and post-sterile ... release activities. Your tasks and responsibilities * Responsible for reviewing batch packet(s) for sub-assembly and pre-sterile packaged product for completion and… more
- Kerry (PA)
- …enter batch data and monitor production workflows using SAP and physical batch records . + Verify batch integrity and troubleshoot discrepancies to ... will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that...to detail. + Preferred + Proficiency in SAP for batch entry and production tracking with handheld scanners and… more
- Kerry (PA)
- …enter batch data and monitor production workflows using SAP and physical batch records . + Verify batch integrity and troubleshoot discrepancies to ... will demonstrate strong attention to detail and expertise in batch management using SAP software. You will ensure that...Safety Mindset + Preferred + Proficiency in SAP for batch entry and production tracking with handheld scanners and… more
- Actalent (Philadelphia, PA)
- …complete required documentation to comply with Federal regulations and assist with batch - record close-out. + Maintain product-related records as required. ... + Author and revise SOPs and Batch records as needed. + Ensure all...cleanroom, packaging, aseptic techniques, and sanitization. + Proficiency in batch record management and finish GMP manufacturing.… more
- Actalent (Philadelphia, PA)
- …complete required documentation to comply with Federal regulations and assist with batch - record close-out. + Maintain product-related records as required. ... + Author and revise standard operating procedures (SOPs) and batch records as needed. + Ensure all aspects of aseptic manufacturing are conducted to maintain… more