- Novo Nordisk (West Lebanon, NH)
- …with direct/indirect referral: none Essential Functions + Perform activities to support Batch Release + Coordinate with Supply Chain Planning to ensure ... running Release performance board + Manage applicable batch release checklists using Styx + Verify...Release of Formulation batches/Production support batches + Timely review of monthly critical logs o Water/Clean steam … more
- Lilly (Indianapolis, IN)
- …**Position Brand Description:** The (Sr.) Principal Associate/Advisor QA - Qualified for Batch Release is responsible for final disposition of Active ... The (Sr.) Principal Associate/Advisor - QA - Qualified for Batch Release ensures that all batches meet...quality support of API with the focus on holistic review of key activities associated with or impacting the… more
- Danaher Corporation (Duncan, SC)
- …delivery of solutions that safeguard and improve human health. What you'll do: + Review batch documentation records to ensure goods are being released in ... internal procedures in a timely and thorough manner + Review Certificates of Sterility / Irradiation to ensure that...plans to meet agreed KPI's. Certify finished goods for release to customer Who you are: + Bachelor's degree… more
- Catalent Pharma Solutions (Hanover, MD)
- …validation protocols and reports and SOPs + Compile and report performance metrics for Batch Review and Release + Contributes to process improvement of ... of cell and gene therapy products + Independently executes batch record review for completeness, accuracy and...and cGMP requirements + Understand risks and delays to batch release and communicate appropriately + Identify… more
- ThermoFisher Scientific (Cincinnati, OH)
- …disposition process, ensuring compliance with all relevant directives and procedures. Compile and review batch release documentation packages to ensure they ... We are currently seeking a dedicated and daring Quality Specialist III-Supervisor Batch Disposition to join our world-class manufacturing team in the United States.… more
- Boehringer Ingelheim (Athens, GA)
- …by SOP. + Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release . + Performs review and approvals of APHIS Form ... this position is review and approvals of batch records, government release documentation and ...of product as needed. + Performs usage decisions for batch release in SAP + Performs second… more
- BeiGene (Hopewell, NJ)
- …management of: Material and Product Release floor activities, material complaints, Batch Release Key processes and QA objectives, whilst adhering to ... Person, interacts with EU QPs as needed for European batch release . + Support QA floor activities...availability of adequate competent resources to carry out the review and release of materials and product… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... progress and final products. This includes reagents, components and instrumentation-related products to ensure they are on the right path. + Generate standard operating procedures to define and improve quality system functions. **Qualifications:** The… more
- BeiGene (Hopewell, NJ)
- …events requiring documented review and action. + Ensuring that the QA batch release function meets or improves key performance indicators (KPIs). + ... Responsibilities:** + Supervises direct reports within the Manufacturing QA Team, assist with batch review and release , as necessary. QA, Mfg. shop floor QA… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …functions for plasma, pooling and fractionation that may include plasma pool shipment release , batch record review , pooling/fractionation batch ... The Quality Supervisor II/III will also perform tasks for Pooling through Fractionation Batch Release and other related Quality functions. He/she may also… more
- Kelly Services (Raynham, MA)
- …and evaluations. This includes activities related to Inspection and Testing, Batch Release and Records Management. **Position Duties and Responsibilities:** ... **Records Review Technician:** Schedule: Monday - Friday 2:00 pm - 10:00..._Batch Release and Records Management_ Audits batch records to ensure… more
- Kelly Services (Barceloneta, PR)
- …Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release . . Act as contact person for projects as required. . ... the capability of meeting product quality requirements prior to release . . Evaluate all deviations documented in batch...into the lot restriction management system. . Assemble the batch record review package and label per… more
- PCI Pharma Services (Rockford, IL)
- …documentation. 7. Assist with providing quality related metrics. 8. Performs finished product batch release of approved production lots. 9. Meet with management ... documentation for requested production work orders. 2. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer… more
- Lilly (Cincinnati, OH)
- …management etc). + Track and monitor quality metrics for trends at the CMs. Support batch release activities by: + Complete batch record and media fill ... for in process issues and escalate as needed. + Review and provide approval for CM procedure changes. +...Provide approval of Certificate of Analysis or other similar batch release documentation for internal and external… more
- Verista (Boston, MA)
- …facility including start-up of assembly, packaging and label operations + Responsible for batch disposition activities. Review batch data, including batch ... to determine acceptability of product disposition. + Responsible for review and approval of COAs, and product release...QA support and oversight of GMP manufacturing operation including batch release + Experience with ATMP drug… more
- WuXi AppTec (Philadelphia, PA)
- … records for assigned clients * Review and approve executed Manufacturing batch records. * Prepare Manufacturing release checklist and COA's * Stay current ... being the QA single point of contacts for clients. Review and approve manufacturing batch records, non-conformances,...in accordance with cGMP. Prepare Certificate of Analysis for batch release . Details: + 100% Onsite at… more
- PCI Pharma Services (Bedford, NH)
- …to the manufacture of both clinical and commercial products. **Job Duties** + Perform review of batch documentation for release of internal and external ... review in support of business needs including maintaining batch status and communicate release needs throughout the organization + Review and approve… more
- BeiGene (San Mateo, CA)
- …QPs in EU. + Provide quality support on product commercial supply eg timely batch release + Support GCP inspections in IMP manufacturing perspective + Execute ... compliant with regulatory requirements and BeiGene standards. + Perform batch record review + Lead batch...and manufacturing function + Prior experience in commercial GMP batch release + In-depth knowledge of Quality… more
- PCI Pharma Services (Rockford, IL)
- …with customers and internal departments concerning proper documentation technique, quality control and batch release to meet due dates. + Company liaison with ... maintaining and collecting team Quality metrics. + Present Executed Batch Record review status at the Daily...Qualified Persons (QP's) and PCI US concerning quality control batch release and randomizations. + Prepares and… more
- ThermoFisher Scientific (Manati, PR)
- …or processes to fulfill quality related improvements. + Supports QA in the areas of batch record review and Product release as needed and directed by ... & Technical Services group to assist in the timely review of implemented manufacturing, quality control and/or facility records...control and/or facility records to meet required timelines for batch release . **A Day in the Life:**… more