- Eisai, Inc (Raleigh, NC)
- …plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review , SOP writing, auditing, batch ... foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness,… more
- Aequor (Houston, TX)
- …and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) o Problem solving in a cross-functional setting, and participation ... on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert (SME), Level I, for...to read and comprehend GMP documents (ie SOPs, logs, Batch Records ) Computer Skills Proficient in the… more
- Merck & Co. (Rahway, NJ)
- …semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Interface with key stakeholders within the design team, molding team,… more
- Aequor (Thousand Oaks, CA)
- …and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval, ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… more
- Repligen (Hopkinton, IA)
- …and file records appropriately.Process requests and generates labels and batch records for production.Documentation Archival, on and off-site.Assist and ... timely manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject… more
- Merck & Co. (Durham, NC)
- …all Good Manufacturing Practices (GMPs), safety, and environmental regulations.- Review and approve automation documents, preventive maintenance, and SOPs to ... Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic… more
- Insmed Incorporated (San Diego, CA)
- …participate in the process execution within a Pilot Plant non-GMP manufacturing environment. Review batch records , SOPs, raw material specifications, ... protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert… more
- Eisai, Inc (Exton, PA)
- …and preventive actions.6. Oversee and coordinate the preparation of bill of materials, batch records , SOPs, and close-out reports for Biologics Pilot Plant ... and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's discretion.5. Lead… more
- RESILIENCE (West Chester, OH)
- … records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified Provides constructive ... feedback to individuals executing batch records and communicates best practices to...Communicate clearly with cross-functional teams Supports QA processes including batch record review and quality… more
- IntePros (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... all process equipment are within required specifications. Performs in-line review of batch record (MPI)...when the audit was conducted. Proactively identify gaps in batch records to mitigate deviations and documentation… more
- Suja Life LLC (Oceanside, CA)
- …batching processes, formulations, and production workflows. Ability to read and interpret batch records , SOPs, and technical documents. Excellent attention to ... and monitor batching equipment, ensuring proper mixing, temperature, and ingredient sequencing. Record and reconcile all batch data in NetSuite, including raw… more
- Aquestive Therapeutics (Portage, IN)
- …the finished product by performing in process checks and documenting findings in batch record . Notifies Quality and Production Supervisors if the product fails ... of the Packaging Specialists during the packaging of a batch and during the closing of a batch...pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department… more
- Premier Orthopaedics (Paoli, PA)
- …in a timely manner. Maintains general knowledge of insurance plans accepted by Premier. Records all record requests in the system and reviews HIPAA requirements ... and patient Medical Record Request form prior to the release of patient...cash drawer, daily balances the cash drawer, and closing batch . Protects patients' rights by maintaining the confidentiality of… more
- LanceSoft (Boston, MA)
- …strategic plans, knowledge base, error correction strategies and tactical processes through batch log review , consultation with end users and programming and ... assess user needs to determine feasibility of automating solutions to user issues Review changes in State and Federal regulations to determine the impact on existing… more
- Tolmar (Windsor, CO)
- …and qualification of all direct reports before duties are assigned. Ensures the batch record review process, including prioritization and reviewing ... including but not limited to: line orientation and risk review of all new team members or those transferring....prevent recurrences of a non-conformance. Pre-approves expiration dates on batch records prior to start of manufacturing… more
- UnitedHealth Group (Middletown, NY)
- …or reads minutes Completes Mandatory Education annually Attends/participates in training/ review classes and projects as assigned Handles difficult situations and ... Use guidelines Provides After visit Summary in compliance with ACO guidelines Prepares Batch Report daily to total and balance collections Begins the check in… more
- Berry Global, Inc (Baltimore, MD)
- …meet customer specifications and company requirements. Assist with collecting and filing paperwork. Review batch records using JDE to verify lot production ... from managers, clients, customers, associates, and the general public. Track record of continuous quality improvement and goal attainment. Additional Info Pay… more
- Actalent (Muskego, WI)
- …SQF, GFSI, and PCQI standards. Food safety expertise. Experience in food manufacturing and batch record review . Additional Skills & Qualifications 2+ years ... that is expanding its operations due to increasing customer demands. Responsibilities Review and approve records to ensure compliance. Identify deviations and… more
- Ultragenyx Pharmaceutical (Bedford, MA)
- …that high standards of cGMP are adhered to at all times. Carry out the manufacturing review of the completed batch records in a timely manner per established ... CAPAs Documentation Create, write and revise GMP documents and templates including batch records , SOPs, OJTs and logbooks. Completion of change control forms and… more
- Premier Orthopaedics (Wayne, PA)
- …an authorization or referral, and sends the request to PCP in a timely manner. Records all record requests in the system and reviews HIPAA requirements and ... patient Medical Record Request form prior to the release of patient...cash drawer, daily balances the cash drawer, and closing batch . Protects patients' rights by maintaining the confidentiality of… more
