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Assists in the setup and execution of automated visual inspection, autoclave, depyrogenation oven, and steam in place sterilization studies. 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. Writes validatio
Posted 1 day ago
Conducts routine inspection, testing and release of samples under general supervision. Adheres to cGMP requirements and SOPs. Compiles data for documentation of test procedures. Responsible for standardization and maintenance of laboratory equipment. Reviews data obtained for compliance specifications and reports abnormalities. Writes and reviews product specifications as required. May assist
Posted 1 day ago
Directs and provides expert knowledge in the day to day function of Quality Control. Identifies, recruits, and retains top notch talent. Champions Aji Bio Pharma's culture and empowers employees to take responsibility for their jobs and goals. Coach, mentor, engage, and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportuniti
Posted 1 day ago
Performs in process and finished goods release testing for routine water and product as needed. Prepares method qualification protocols & reports, and performs qualification testing. Reviews and approves data and authors trend reports. Responds to client questions and participates in client facing activities. Serves as departmental representative on cross functional teams. Performs notebook s
Posted 1 day ago
Writes and executes installation, operational, and performance qualification protocols for critical production equipment, utilities and processes which may include HVAC systems, clean compressed air systems, WFI systems, purified water systems, clean steam systems, nitrogen systems, fermenters, purification skids, vial washers, controlled storage units, autoclaves, depyrogenation ovens, SIP proces
Posted 1 day ago
Manages disposition activities related to support services and materials to ensure compliance to internal and regulatory requirements. Facilitates the investigation of deviations and adverse events occurring during manufacturing activities. Evaluates the impact of deviations and adverse events to product quality and assigns product disposition. Reviews production batch records and associated data
Posted 1 day ago
Directs and provides expert knowledge in the day to day function of the Microbiology department. Identifies, recruits, and retains top notch talent. Champions Aji Bio Pharma's culture and empowers employees to take responsibility for their jobs and goals. Coaches, mentors, engage and develop the team, including overseeing and and learning opportunities. Sets performance standards and encourages
Posted 1 day ago
Provides QA oversight of the GMP deviation, complaint and CAPA quality system to ensure the adequacy of investigations and timely implementation of effective CAPAs to prevent reoccurrence of quality events. Facilitates the investigation of deviations, complaints and adverse events associated with Aji Bio Pharma produced drug product and drug substance. Acts as the liaison between Aji Bio Pharma's
Posted 1 day ago
Lead and/or collaborate with method establishment (eg. method verification, qualification, transfers and validations) for compendial assays and other chemistry methods including, but not limited to, ELISA, CE SDS, HPLC, cIEF and Mass Spectrometry). Perform routine analysis and testing, including but not limited to compendial assays such as pH, osmolality, extractable volume, density, particulate m
Posted 1 day ago
Manages customer audit program, including scheduling audits, hosting audits, communicating and coordinating with internal subject matter experts, responding to audit findings, and tracking completion of corrective actions. Manages internal audit program, including generating an audit schedule, conducting audits, writing audit reports, and evaluating responses to audit observations. Manages vendor
Posted 1 day ago
Manages clinical or commercial GMP manufacturing projects governed by a contract between Ajinomoto Bio Pharma Services and client including but not limited to tech transfer, DS production, DP production, ADC production or Crystalomics. Responsible for development of project timelines and tracking of contract deliverables. Hosts project meetings to provide status update to clients and internal cros
Posted 1 day ago
Develops scalable processes with improved product yield and reduced costs for manufacturing systems. Designs experiments and writes protocols, executes processes with minimal supervision. Conducts experiments in Process Science laboratory following protocols and accurately documents procedures and results in lab notebooks. Performs data analysis, and prepares results summaries and reports. Author
Posted 1 day 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 quality operations within m
Posted 1 day ago
Serves as the regulatory affairs subject matter expert (SME) for the company. Collaborates with, and advises clients and external stakeholders on the development of regulatory strategy for submission of new product applications and changes to previously approved applications. Tracks and maintains licenses and company submissions as required by applicable regulatory agencies. Keeps abreast of local
Posted 1 day ago
Cultivates collaborative business partnerships through HR mentorship to employees and managers with regard to career development, recruiting, performance management, compensation, training, policy interpretation, LOA etc. Partners with hiring managers to understand organizational needs and ensuring the proper identification and selection of candidates within established timelines and legal compli
Posted 1 day ago
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