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Follows and executes existing processes and procedures. Performs calibration on various instrumentation and controls throughout a cGXP environment. Works with various departments to schedule routine and non routine calibration work. Uses mathematics to solve process measurement related problems as well as to derive and interpret specifications for instrumentation/controls
Posted 1 day ago
Receipt, inventory, and issuance of raw materials in GMP storage areas Restock and stocking of gowning and consumables at various company sites Distribution of Non GMP packages throughout Aji Bio Pharma campuses Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal
Posted 2 days ago
Maintain and troubleshoot automated control systems Provide input and author URS, FRS, SAT, I/O/PQ, and SOP documents Provide design input in the specification of automated control systems Research new technologies and make recommendations Document changes to systems per change management procedures Travel between facilities to support all functional areas Regular and rel
Posted 2 days ago
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
Posted 3 days ago
Performs environmental monitoring within the microbiology laboratory, manufacturing suites, clean rooms, and drug product operations. Performs enumeration and gram staining of bacterial colonies. Sampling and analysis of the utilities including water, steam, and compressed gasses. Support process qualification of water, HVAC, and other systems. Must gown qualify and exemp
Posted 4 days ago
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. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and i
Posted 4 days ago
Together, Let's Make A Difference. At Ajinomoto Bio Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market. Every team member, from manufacturing and quality programs to
Posted 4 days ago
Together, Let's Make A Difference. At Ajinomoto Bio Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market. Every team member, from manufacturing and quality programs to
Posted 12 days ago
Provides leadership, development and management skills in building a cohesive team of talent acquisition professionals ensuring their added value to the candidate care experience and interactions with hiring managers. Leads diversity recruiting strategies to attract a diverse workforce to the company by hiring talented people of varied backgrounds, experiences and styles.
Posted 16 days ago
Leads to identify, analyze, and evaluate risk management plans following Quality Risk Management process per ICH Q9, collaborates with Subject Matter Experts (SME) for technical input, maintain the Risk Register, and tracks deliverables to closure Leads implementation and improvement of the Data Integrity Program as the Data Integrity Officer, ensures compliance to the Da
Posted 16 days ago
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
Posted 16 days ago
Participate as an internal audit team member for inspection readiness preparation Prepare submissions of license applications and renewals. Track and maintain licenses and company submissions as required by applicable regulatory agencies. Collect, collate and evaluate data for routine internal and customer regulatory reports. Maintain current knowledge base of existing an
Posted 16 days ago
Provide quality, timely and accurate analysis, design, configuration, and support; including daily technical support to end users. Configure process flows for development, testing, and production environments in accordance with approved protocols and scripts. Provide project management for the implementation of new and/or revised processes within the electronic QMS. Maint
Posted 16 days ago
Perform preventive and routine maintenance for pharmaceutical lyophilization system. Troubleshoot complex problems and guide staff in implementing repairs. Maintain equipment in use ready, compliant state. Monitor, respond to, and correct issues generating equipment alarms. Provide recommendations for, and implement upgrades and improvements. Author, review, and update ma
Posted 16 days ago
Identify, investigate, resolve, and prevent compliance/deviance issues by real time review of batch records and walk through of the manufacturing areas Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices. Independently performs qu
Posted 16 days ago
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