- 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)
- …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
- 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
- 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
- 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
- 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
- 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
- Mallinckrodt Pharmaceuticals (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
- 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)
- …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
- Merck (Durham, NC)
- …steady-state production and/or continual process improvement. + Authoring and reviewing documents and SOPs. + Batch Record Review + eLog Review + Lead ... Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance… 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