- Merck & Co. (Rahway, NJ)
- …NJ facility. Responsibilities of the role include but are not limited to: Lead , prepare for and/or support batch processing readiness and execution activities. ... project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant...GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to… more
- Merck & Co. (Rahway, NJ)
- …while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, ... with indirect staffBatch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change ... CMC, and IT. This individual will support the MES team with electronic batch record (EBR) updates and system improvements, support applicable process and facility… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Batch Release Lead **Grade:** L3 **Hiring manager:** Martin Razo **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion ... infectious diseases and bring hope to patients and their families. Your job, as QA Batch Release Lead within our Quality Assurance team, will be to lead … more
- Sanofi Group (Framingham, MA)
- **Job Title:** Batch Release Lead **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... was possible. Ready to get started? **Main Responsibilities:** + Overseeing the batch release process to ensure compliance with regulatory requirements and… more
- West Pharmaceutical Services (Williamsport, PA)
- Batch Release Technician Requisition ID: 70683...documents by QA. Reports directly to the Value Stream Lead or Business Unit Manager. Ensures all batch ... efforts. **Job Summary** Responsible for the co-ordination and reviewing of all batch release activities and documentation in accordance with customer and… more
- Lilly (Indianapolis, IN)
- …Representative (AQR) in Indianapolis Parenteral Manufacturing (IPM) is responsible for final batch release of Semi-Finished products and supports and assists the ... regulatory inspections and internal audits. **Responsibilities:** + Performs final batch disposition of semi-finished drug product batches for Indianapolis… more
- Lilly (Durham, NC)
- …high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market. + Lead , mentor and coach site personnel on quality ... for people around the world. **Position Description** The Quality Assurance Incoming Batch Disposition team assures patients worldwide of safe and efficacious drug… more
- Global Foundries (Austin, TX)
- …are completed before cutover. + Monitor post-go-live defects and manage resolution through release processes. + Communication & Coordination + Lead daily cutover ... and other Enterprise applications. + Data Migration Oversight + Lead master and delta data loads for GL, cost...Led teams and change management strategies for cutover & release management + Familiarity with transport trackers, batch… more
- Cardinal Health (Helena, MT)
- …evaluations of abnormalities in sterilization processing and batch records for product release and lead special studies in support of product release . ... + Perform sterilization process development, chamber qualification/validation, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract… more
- Caris Life Sciences (Phoenix, AZ)
- …production activities, and performing order picking, product labeling, inspection, signing off batch record and release forms, preparing QC samples, material ... release and transfer. The Kitting Lead will train new and existing kitting associates and...component material information (eg, part number, lot number) on batch records. Ensure that kitting process steps are documented… more
- ThermoFisher Scientific (Middletown, VA)
- …systems and metrics to demonstrate the effectiveness of QA Audit processes. The Batch Record Reviewer Lead ensures that all diagnostic products released for ... Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The QA Audit Lead is responsible for leading the QA Audit teams to ensure compliance… more
- PNC (Strongsville, OH)
- …have an opportunity to contribute to the company's success. As a Software Engineer Lead within PNC's Technology organization, you will be based in Pittsburgh, PA or ... This position is for Run the Bank production support Lead supporting Capital Market ALM Funding Desk critical Business...Troubleshoot day to day file transmissions and reports issues, batch job failures, data and process issues related to… more
- Lilly (Concord, NC)
- …device or food processing industries + Manufacturing Execution Systems and electronic batch release . + Continuous improvement (Lean, Six Sigma methodologies) + ... perfect opportunity! During the project phase, the Parenteral (PAR) Operators (Entry to Lead roles) will support start up activities required to bring the area into… more
- Lilly (Concord, NC)
- …device, or food processing industries + Manufacturing Execution Systems and electronic batch release + Continuous improvement (Lean, Six Sigma methodologies) + ... now is the perfect opportunity! During the project phase, the Parenteral (PAR) Lead Operator will support start up activities required to bring the aseptic isolator… more
- Fujifilm (Santa Ana, CA)
- …and follow up of actions and review, obtain corrections, and completed actions to release batch records post production. **_THIS ROLE WILL WORK 3rd SHIFT ... **Position Overview** **Position Description** We are hiring aQA In Process Inspector Lead . TheQA In Process Inspector Lead willensure quality of product by… more
- University of Colorado (Aurora, CO)
- …qualification efforts + Perform protein biologic analytical tests to support cGMP batch release including HPLC/UPLC, DLS, pH, and UV-Vis spectrophotometry, ... + Perform regenerative medicine cellular therapy analytical tests to support cGMP batch release including Product thawing, Cell Counting, Endotoxin, and Gram… more
- Merck (Rahway, NJ)
- …facility. **Responsibilities of the role include but are not limited to:** + Lead , prepare for and/or support batch processing readiness and execution ... degree of technical, project, and people management responsibility. This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth… more
- WuXi AppTec (Middletown, DE)
- …* Provide timely review and approval of microbiological data to meet batch release and stability program timelines. Regulatory Compliance * Ensure ... **Overview** The QC Microbiology Lead will manage all microbiology laboratory activities at WuXi STA's drug product manufacturing site in Middletown, DE. This role… more
- WuXi AppTec (Middletown, DE)
- …activities. * Ensure timely review and approval of analytical data to meet batch release and stability program timelines. Regulatory Compliance * Ensure all ... **Overview** The QC Analytical Lead is responsible for establishing and managing all...Lead will ensure timely and accurate execution of release and stability testing to support manufacturing and packaging… more
