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Performs various manufacturing tasks under the guidelines of established SOP and cGMP regulations. Performs visual inspection. Labels and boxes filled goods. Prepares and stocks packaging and labeling materials or supplies as needed. Keeps equipment and production areas clean to meet regulatory requirements. Completes equipment documentation as required, including logbooks and binders. Maintains p
Posted 13 days 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 oppor
Posted 21 days ago
Prepares and distributes monthly financial reporting including consolidated, segment and departmental operating results, and provides quantitative analysis of key variances and trends. Coordinates with other contributing parties to complete analyses and reporting processes in a timely and quality fashion. Responsible for preparing and submitting monthly reporting packages to parent company. Answer
Posted 21 days ago
Initiates and/or supports complex investigations and resolution of issues / potential problems related to Drug Product Manufacturing. Coordinates and supports interdisciplinary working teams with recommendations, advice and action plans for complex investigations, change controls, gap analyses and risk assessments. Authors and revises compliance, change controls and other technical documentation.
Posted 22 days ago
Transfers raw materials from warehouse staging area to production suite. Labels materials for applicable client use. Conducts inventory and storage of raw materials in production area. Prepares components, buffers and other solutions and/or operates autoclave, washer, or depyrogenation oven. Completes in process analytical testing as needed to confirm suitability of solutions and submits samples t
Posted 23 days ago
Operates filled drug product offloading equipment. Accurate receipt and counting of filled units from Fill Finish manufacturing. Responsible for product transfers to Materials Management. Responsible for assisting with pre and post Line Clearance, and Good Documentation Practices (GDP). Perform Bulk Packaging and Labeling of Vials or Syringes. Follow all proper gowning procedures. Regular and reli
Posted 30 days ago
Performs routine and non routine HPLC, cIEF, and particle size analysis according to Standard Operating Procedures to support in process, release, and stability testing in a manner consistent with cGMP requirements. Analyzes data and results and presents conclusions to the supervisor in tabular, graphical, and written format. Maintains laboratory inventory of reference standards and supplies. Assi
Posted 1 month ago
Conducts routine and non routine HPLC analysis according to standard operating procedures to support in process, release, and stability testing in a manner consistent with cGMP requirements. Compiles data for documentation of test procedures in a manner consistent with GDP requirements. Analyzes data and results and presents conclusions to supervisor in tabular, graphical, and written format. Revi
Posted 1 month ago
Coordinates flow of materials within or between departments to support production demands. Reviews Master Production Records and performs comparison to work orders to ensure accuracy and availability of require materials. Tracks receipt and release of all production materials including raw materials and client supplied materials pertinent to production batches. Authors specifications for consumabl
Posted 1 month ago
Performs cGMP documentation/data review in support of manufacturing operations (e.g. logbooks, labels, etc.). Performs AQL inspection of final filled product. Performs line clearance operations in support of manufacturing processes. Generates, reviews, approves, and reconciles labels for cGMP use. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Respons
Posted 1 month ago
Manage administrative duties of direct reports such as, timecards, attendance tracking, etc. Projects as assigned by management. Communicate shift project status to visual inspection leaders. Participate in the interview and selection of potential visual inspection candidates. Responsible for initiating and investigating product/process deviations. Generate purchase requests for material/equipment
Posted 1 month ago
Our Director will create and innovate at the strategic level, while providing experienced knowledge of the Quality Control (QC) and Stability functions. Being a leading CDMO, we work with a multi product and multi client business environment. We expect you to build effective partnerships with department heads to help drive the business toward achieving company objectives. This role will lead all a
Posted 1 month 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 meetings and group trainings.
Posted 1 month ago
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