Conducts and reviews routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena. Performs releases testing assays for in process, final product, raw materials, stability and other routine samples. Adheres to cGMP requirements and SOP's. Compiles data for documentation of test procedures. Responsible for st

Maintain reliability systems and programs to improve uptime. Track and analyze historical data of operations and KPIs. Provide input for continuous improvement in the areas of Manufacturing, facilities and engineering. Provide input and author SOPs, Validation Protocols, Deviations, CAPAs and other GMP documentation. Document changes to systems per change management proce

Maintains process equipment in use ready state. Major equipment includes aseptic fillers, isolators, vial washing machines, ovens, and autoclaves. Monitors, responds to, and corrects issues generating process, process support, and laboratory equipment alarms. Completes CMMS entries and required training activities. Travels between facilities to support all functional area

Oversee day to day facilities maintenance activities Ensure staff activities are supervised consistent with tactical plans Train and mentor technical and supervisory staff on best practices Review department output for customer service and compliance Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting pr

Why join Ajinomoto Bio Pharma? Our mission is to help improve the health of humankind. We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which th

Conducts and reviews routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena. Performs releases testing assays for in process, final product, raw materials, stability and other routine samples. Adheres to cGMP requirements and SOP's. Compiles data for documentation of test procedures. Responsible for st

Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Train on required SOP's and execute training curriculum. Prepare materials needed for aseptic operations. Performs various routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Accurately documents data and complet

Oversee daily operations (formulation, filtration, filling and troubleshooting any issues). Batch record review and generation. Strategic planning with drug product manufacturing including defining the schedule, coordinating preparation, and troubleshooting any issues that may arise. Participate in client calls, interactions and meetings including kick off meeting, tours,

Design and implement reliability programs to improve uptime. Participate in design and installation stage of projects for new assets and modification of existing assets. Evaluate existing systems for continuous improvement opportunities. Provide technical support to manufacturing, maintenance and other technical personnel. Provide in depth technical review of all document

Follows method standard operating procedures (SOPs) and conducts analytical method transfer. Develops, qualifies, and validates analytical methods with minimal supervision. Investigates, creates, and develops new methods and technologies for project advancement under limited supervision. Analyzes in process, release and stability samples by battery of analytical methods a

Design and implement reliability programs to improve uptime. Participate in design and installation stage of projects for new assets and modification of existing assets. Evaluate existing systems for continuous improvement opportunities. Provide technical support to manufacturing, maintenance and other technical personnel. Provide in depth technical review of all document

Perform routine analysis and testing in a GMP environment May participate in qualification/verification of assays Assay and documentation review and report writing Maintain personal training records. Attend all required training. May be responsible to provide training as applicable. Regular and reliable attendance on a full time basis [or in accordance with posted schedul

Serves as department technical writer for investigations, including but not limited to EM excursion, deviation, CAPA and out of specification reports. Assigns completion of investigations to other technical writers or EM analysts as needed. Develops technically justified recommendations and resolutions to investigation conclusions and ensures timely completion of reports,

Perform sanitization duties in the cleanroom while aseptically gowned. Accurately record and complete documentation as required, including logbooks and forms in compliance with SOP guidelines. Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit. Administrative tasks including attendance of regularly scheduled departmental mee

Responsible for full lifecycle project management including scope development, detailed engineering, execution, commissioning, qualification, and close out. Maintains a business partner relationship with the program stakeholder and establish the goals, processes execution plans and communication plans that define the expected project outcomes and ways of working. Facilita