- Nitto Denko Corp. (Milford, MA)
- …this opportunity : In this position you will support day-to-day QA Operations activities such as batch record review , release of raw materials, review of ... + Responsible for reviewing, approving, scanning, and binding quality records / batch records , and raw materials...Provide sound decision-making and guidance on all aspects of batch record review and raw… more
- Sanofi Group (Swiftwater, PA)
- …high-performing teams in a matrix environment highly preferred + Ability to meticulously review batch records and documentation to ensure accuracy and ... compliance with regulatory requirements and company standards + Overseeing review and approval of batch records and associated documentation + Ensuring all… more
- ADM (Sabetha, KS)
- …requires to meet demands. + Review all paperwork for accuracy. + Run the batch review report to check for accuracy. + Warehouse movement of product using ... and copy the Regional Inventory Manager. + Run the batch review report weekly to check for...up to and including inventory related functions. + Plant Records Management contact. + Assist Answering Phones. **Requirements:** +… more
- PCI Pharma Services (Bedford, NH)
- …The role supports and provides quality oversight client facing QA Operations including Batch Record Review , Lot Disposition, Investigations, CAPAs and ... compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs...status and communicate release needs throughout the organization + Review and approve master batch records… more
- PCI Pharma Services (Madison, WI)
- …to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review , Lot Disposition, and Quality System ... compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs...status and communicate release needs throughout the organization + Review and approve master batch records… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …production, project management, shipping, and quality groups to ensure timely and compliant batch record review and release. It's an excellent opportunity ... pharmaceutical partners in a global setting. **The Role** + Review and approve batch records ...+ Serve as the primary liaison with clients for batch record review and release.… more
- PCI Pharma Services (Philadelphia, PA)
- …will contact the appropriate + personnel to recalibrate and/or remediate the issue. + Review batch record (MPI) to ensure equipment challenges and hourly ... the audit was conducted. + Identify proactively gaps in batch records and PDRs to mitigate deviations...QA inspectors/auditors, batch record preparation, batch record review , document change… 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… more
- Catalent Pharma Solutions (San Diego, CA)
- …cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison ... between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed … more
- Catalent Pharma Solutions (Kansas City, MO)
- …diploma or equivalent required + Bachelor's degree is preferred + Prior experience in manufacturing batch record review highly preferred + Minimum of 3 years ... packaging material and component requests + Preparation of packaging batch record documentation in compliance with SOPs...documentation in compliance with SOPs and cGMP + Accurately review packaging batch records prior… 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
- PCI Pharma Services (Madison, WI)
- …program. The individual serving in this role will also provide support on batch record review , deviation investigations, CAPAs, and other manufacturing ... support teams + Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate...to cGMPs/ISO and corporate standards + Provide support of batch record review , deviations, and… more
- Bristol Myers Squibb (Summit, NJ)
- …and WCT members. * Performs batch record reviews (BRR) or Electronic Batch Record review by exception. * Ensures that all documentation produced by ... review , author, or approve SOP, WI, master batch records . Safety: * Takes personal responsibility...the deviation and ensures timely entry of the deviation record information in the system. * Maintains deviation metrics… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- …+ Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities ... associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract… more
- RPM International, Inc. (Ellaville, GA)
- …and expediently addressing gaps in data and/or documentation when they arise during post- batch review process. + Review of manufacturing data/settings for ... Job Description ESSENTIAL FUNCTIONS: + Perform post- batch activities in a timely manner, efficiently, and...and/or databases. + Scan and index manufacturing packets and records into company document database. + End production orders… more
- Bristol Myers Squibb (Devens, MA)
- …a local process owner for core QASF systems/processes including but not limited to Alarm Review , Batch Record Review , and the GMP Walkthrough Program. ... incumbent shall flex to support ad-hoc deviation approval or batch record review as requested...systems such as Manufacturing Execution Systems (MES) for electronic batch records ; Enterprise Resource Planning (ERP) such… more
- 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
- 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