- 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
- Merck (Durham, NC)
- …of operations on the production floor, coordination across processing suites, real-time batch record review , execution of aseptic processing requirements ... and reports issues with product accountability and SAP system discrepancies. + Executes real-time batch record review and ensures timely closure of shopfloor… more
- Fujifilm (Research Triangle Park, NC)
- … + Performs pre-production activities, including review and approval of Master Batch Records (MBR), Batch Material Masters (BMM) in SAP, Sampling ... site. This role organizes, maintains, and communicates the status of batch disposition details, and partners cross-functionally, including with external stakeholders… 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
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …internal/external audits related to training. + ** Batch Record Review :** Performtimelyandaccuratereview of batch records to ensure compliance with ... Support updates to manufacturing documentation including SOPs, work instructions, and batch records . + **Standard Work Documentation:** Assistin the creation… 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 (Durham, 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
- Fujifilm (Research Triangle Park, NC)
- …procedures (SOPs) and compliance through GMP documentation review (including batch , formulation, and logbook records ) + Participates in audits, regulatory ... shift scheduling, task delegation, and execution of production plans per batch records and manufacturing standard of work + Leads all shift-level upstream… 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
- 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
- United Therapeutics (Research Triangle Park, NC)
- …safety policies + Review and approve manufacturing documentation, including batch records , deviations, and corrective actions + Lead investigations when ... process deviations or non-conformances occur + Create, review , and revise SOPs and manufacturing procedures to reflect...a diverse workforce + Demonstrated leadership skills + Track record of developing and retaining employees + Knowledge of… more
- United Therapeutics (Research Triangle Park, NC)
- …and safety policies + Review and approve manufacturing documentation, including batch records , deviations, and corrective actions + Lead investigations when ... process deviations or non-conformances occur + Create, review , and revise SOPs and manufacturing procedures to reflect current practices and regulatory expectations… more
- United Therapeutics (Research Triangle Park, NC)
- …and guidelines; accountable for the review and approval of all batch records , deviations and change control, validation and certification activities + ... Oversee and assist in the review and approvals of product packaging and labeling +...in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review , writing and application + Knowledge and experience in… more
- Fujifilm (Research Triangle Park, NC)
- …as needed. + Ensures GMP documents are completed accurately and timely (provides a daily review of batch records and logbooks). + Ensures completion of ... execution. + Ensures the execution and closure of SFOs in Pas-X prior to records being removed from the floor. + Performs other duties, as assigned. Requirements: +… more
- Fujifilm (Holly Springs, NC)
- …of sampling protocols, as directed + Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs) + Supports ... provide standard professional advice and to create reports and analyses for review **Basic Requirements** + Associate degree in Engineering, Life Science or Chemical… more
- EMCOR Group (Raleigh, NC)
- …and dispatch personnel to resolve billing discrepancies * Maintain comprehensive billing records and customer account files in accordance with audit and regulatory ... sales tax, contract terms) **Advanced Billing:** * Perform Billing Batch Reviews * Manage and respond to inquiries via...and track Credit Requests and apply Credits accurately * Review Daily Cash Receipts and ensure proper posting *… more
