- Endo International (Raleigh, NC)
- …reviews, and updates documentation for managing the process, including operating reports, batch records , P&IDs, etc. Reviews operating reports and batch ... operations + Must be able to climb stairs and ladders for equipment installation review , monitoring and troubleshooting. + Must be willing and able to wear PPE… more
- Catalent Pharma Solutions (Morrisville, NC)
- …and precisely represent the work done during production. The Batch Record Reviewer is responsible for executing the review and successful release of all ... Record Reviewer . Documentation in the Manufacturing Batch Records represents the Intermediate and Final...and release of Catalent products. **The role:** + Execute batch record review for completeness,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …quality in meetings. Specific duties will depend on the assignment and may include review of manufacturing or testing records , preparation or review of ... analysis, auditing, data analysis for stability, etc. (ie Documentation review , product investigations, product release, internal and external audit support,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …solutions and services in more than 110 countries and regions. The Physical Records Management (PRM) Specialist I is an entry level role with intermediate knowledge ... and procedures using technical knowledge / concepts to accurately process (receive, review , search and retrieve) completed GMP controlled document packets managed by… 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
- 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
- Sumitomo Pharma (Morrisville, NC)
- …product manufacturing and aseptic techniques. + Relevant experience and knowledge of manufacturing, batch record review , and/or analytical analyses for the ... + Responsible for providing QA review /approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the… more
- Amgen (Holly Springs, NC)
- …in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]) + Complete washroom activities: cleaning ... most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional… more
- Catalent Pharma Solutions (Morrisville, NC)
- …and equipment + Fill product in aseptic processing area in compliance with SOPs, batch record , and cGMPs + All other duties as assigned **The Candidate:** ... every patient, consumer, and Catalent employee.** **The Role:** + Review experimental product trial paperwork to ensure use of...Prepare and assist in the preparation of all production batch requirements + Perform all steps and processes necessary… more
- Novo Nordisk (Clayton, NC)
- …+ Perform routine cleaning and good housekeeping as needed for assigned areas + Review electronic batch records real-time to ensure compliance to Standard ... storage & process waste systems preferred + Ability to work with electronic batch records , automated process equipment, and/or DeltaV or Syncade preferred +… more
- Fujifilm (Holly Springs, NC)
- …and preventive action (CAPA) in response to process deviations + Supports generation and review of master batch records (MBRs) and sample plans, as ... analytics, including but not limited to closing deviations, generating master batch records , and data system improvement initiatives. **Company Overview**… more
- Actalent (Wilson, NC)
- …for manufacturing processes across departments and external units. + Draft master batch records and protocols for development, stability, and validation batches. ... to project teams, especially regarding scale-up, new equipment, validation, and batch manufacturing. + Prepare the manufacturing site for new product introduction.… more
- Amgen (Holly Springs, NC)
- …most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional ... to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class...changes, deviations, CAPAs, and capital projects. + Perform quality review and approval of documents to support facility commissioning… more
- Amgen (Holly Springs, NC)
- …and key stakeholders. + Ensure work order documentation is completed accurately. + Review maintenance reports, forms, plans and records . + Identify waste, ... drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies...to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class… more
- Pfizer (Rocky Mount, NC)
- …support Computer Systems. Review and approve investigations, commitments, procedures, batch records as they relate to CSV applications. Provide technical ... assigned projects. Develop and design validation strategies, studies, draft and/or review project validation plans and documentation. Participate, present and defend… more
- Kelly Services (Clayton, NC)
- …learn systems and equipment outside of primary responsibility + Record and review data in Batch Production Records (BPRs) and associated forms ... environmental monitoring + Actively participate in and support event response activities + Review and provide input to SOPs and related documents, as required +… more
- Kelly Services (Clayton, NC)
- …**What You'll Do** * Record and review production data in Batch Production Records (BPRs) * Operate and inspect manufacturing equipment * Follow all ... safety and environmental procedures * Support production operations as needed **Top Qualifications** * **High school diploma or equivalent** required * **1+ year of manufacturing experience** * Experience in an **FDA-regulated environment** preferred * Ability… more
- Actalent (Clayton, NC)
- …in event response and deviation investigations as needed. + Record and review data in batch production records (BPRs) using Good Documentation ... Practices (GDP). + Provide input on SOPs and other controlled documents. + Train peers in sanitization procedures and cross-functional systems. + Follow all safety and environmental protocols in daily operations. + Support process alignment across Aseptic Core… more
- Pfizer (Rocky Mount, NC)
- … risk assessment documents. Review investigations, commitments, procedures, and batch records . Provide technical input and complete SME impact assessment ... assigned projects. Support development and design of strategies, studies, draft and/or review project validation plans and documentation. + S/he to provide input in… more
- Pfizer (Rocky Mount, NC)
- … risk assessment documents. Review investigations, commitments, procedures, and batch records . Provide technical input and complete SME impact assessment ... projects. Support development and design of C&Q strategies, studies, draft and/or review project validation plans and documentation. + S/he to provide input in… more
