16 to 30 of 31
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 23 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 23 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 23 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 23 days ago
Champions Aji Bio Pharma's culture and empowers employees to take responsibility for their jobs and goals. Engages employees by creating a climate in which they want to do their best. Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management. Maintains employee work schedules
Posted 23 days ago
Manages the documentation/data review in support of manufacturing operations (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) with junior staff. Designated subject matter expert during AQL inspection Assists in real time review of documents on the manufacturing floor Assists in the review and approval of executed and non execu
Posted 23 days ago
Maintains laboratory and process support equipment in use ready state. Monitors, responds to, and corrects issues generating laboratory and process support equipment alarms. Orders and stocks supplies, spare parts, and equipment. Completes CMMS entries and required training activities. Travels between facilities to support all functional areas. Regular and reliable attend
Posted 23 days ago
Performs, as part of a team, a wide variety of tasks to maintain facilities, utilities, labs, and cleanrooms in use ready, compliant state. Monitors, responds to, and corrects issues resulting in Building Management System (BMS) system alarms. Interfaces with customers, vendors, and team members in support of facility initiatives, work request completion, or other duties
Posted 23 days ago
Provides high level administrative support and assistance to the President & CEO and/or other executive staff members. Assists with administrative responsibilities, such as drafting email communications, memos, and other communications on behalf of the executive team. Manages executive's calendars, including scheduling appointments, re scheduling as needed, and prioritizi
Posted 23 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 23 days ago
Performs various manufacturing tasks including sterile filtration, formulation, in process testing, and preparation of formulation components, and product development project preparations in accordance to established Standard Operations Procedures (SOP's) and cGMP regulations. Support with the implementation of production and manufacturing procedures and schedules. Effect
Posted 23 days ago
Performs various routine manufacturing tasks under the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations. Coordinates the implementation of production and manufacturing procedures and schedules. Performs visual inspection of tanks and bulk drug substances. Prepares components, media, buffers, and other solutions as needed. Accurately doc
Posted 23 days ago
Author and /or revise all client specific Batch Records for both clinical and commercial use. Technical review of client batch record. Ensure technical review of Non GMP records are approved and then sent to client for billing. Work with validation teams from both Aji Bio Pharma and our client to author PPQ Batch Records for clients applying for commercial use of their dr
Posted 23 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 23 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 23 days ago
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