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Manage facilities staff, activities and projects in support of biopharmaceutical manufacturing facilities both GMP and non GMP. Train and mentor supervisory staff on managerial acumen Review designs for consistency with needs and compliance Implement and oversee Security contractor, systems, and Access Report adherence to engineering project budgets and timelines Space pl
Posted 1 day ago
Under the guidance of senior manufacturing operators, performs various routine manufacturing tasks while adhering to the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations. Supports the implementation of production and manufacturing procedures. Performs visual inspection of tanks and bulk drug substances. Prepares components, media, buffe
Posted 4 days ago
Save, log, and distribute all incoming signed document/contracts (i.e. proposals. Change Orders, Cancellation Memos, Master Supply Agreements, Non Disclosure Agreements, and other contract related documentation) in Aji Bio Pharma's electronic records. Maintain and update Aji Bio Pharma Log of Process Executed Documents. Create and manage Sales Orders in ERP system. Mainta
Posted 3 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 5 days ago
Coordinates document changes within an electronic document management system. Issues batch records, laboratory notebooks, and logbooks for use in GMP production and testing activities. Interfaces with document authors and reviewers to process document changes within project timelines and in accordance with established procedures. Facilitates client review and approval of
Posted 6 days ago
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
Posted 6 days ago
Oversees daily operations including formulation, filtration, filling and troubleshooting any issues. Batch record review and generation (Client calls and Project Management interactions) Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting. Client calls, interactions and meetings (kick off meeting, tours,
Posted 8 days ago
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 11 days 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 12 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 12 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 14 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 14 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 22 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 26 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 26 days ago
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