- 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
- 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
- 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
- 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 (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
- 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
- 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
- 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
- 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
