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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 1 day 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 day ago
Perform inventory and project profitability analyses, identify and concisely communicate issues, and recommend solutions or process improvements. Responsible for management of the Fixed Asset process, policy, and procedures, including figuring out additions/retirements, confirmation of assets and impairment review, and working with third party consulting firm on property tax requests as well as an
Posted 1 day 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 day 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 day 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 day ago
Follows SOP's for Receiving, Raw Material Movement, Raw Materials Specifications, Raw Material Inventory, Material Transfer, CSM Inventory, Final Product Inventory and Final Product Shipping, Sampling and Dispensing. Loads and unloads company trucks. Responsible for the distribution of all GMP and non GMP supplies, materials and equipment across company sites. Oversees stocking of gowning and cons
Posted 1 day 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 exemplify cleanroom behavior. M
Posted 1 day ago
Performs various routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Implements production and manufacturing procedures. Performs visual inspection. Prepares components, media, buffers, and other solutions as needed. Accurately documents data and completes batch records as needed. May cross train and/or focus in various manufacturing tasks including fill/f
Posted 1 day ago
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 1 day 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 day 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 day 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 day ago
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