Performs lab logistics functions including sample management, testing coordination, and shipping & receiving. Pipettes samples and applies barcode labels as needed for testing and shipping purposes. Responsible for monitoring and maintenance activities for all QC storage units, samples, and support equipment across several locations. Timely buffer and reagent preparation

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

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

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

Leads all aspects of quality assurance at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules. Manages key quality assurance metrics/site goals, supports critical program milestones, and drives continuous improvement initiatives that are essential to meeting client and business needs. Establi

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

Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into Aji Bio Pharma's manufacturing operations. Provides technical and theoretical support to manufacturing staff within area of specialty. Writes and reviews SOPs, compliance, change controls, risk assessments and other technical and quality related documentation. E

Documentation Preparation (Protocol and Report Generation). Protocol Execution. Training, datbase entry, and audit support. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consiste

Responsible for performing validation documentation preparation and review for manufacturing process, equipment and utilities in accordance with relevant guidance documents and current industry best practices. Executes validation protocols. May be tasked with training lower level personnel. Acts as Validation subject matter expert for regulatory and client audits. Partici

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

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

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

Performs various routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Performs final product assembly, packaging, and labeling and has completed required qualifications where applicable. Accurately documents data under cGMP guidelines. Labels and boxes filled goods. Assists other technical personnel on issues and problems. Collects a

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

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