AddressJob Title
Quality Assurance Tech II
Requisition
JR000013255 Quality Assurance Tech II (Open)
Location
Hobart, NY (Pharma) - USA036
Additional Locations
Hobart, NY
Quality Operations Area - Tech I (In-Process Batch Records Meet Compliance Requirements)
Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP's prior to final product release. Coordinates with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder. Assists in training operators on proper documentation. Reviews quality control checks during and after production. Ensures timely flow of records and product to next stage. Reviews equipment records and logs for completeness and accuracy when required. Maintains various reports for supervisor/manager by inputting/updating pertinent data. Maintains knowledge of cGMPs, most current manufacturing instructions, SOP's, etc. may prepare revisions as needed. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change. Assists with issuance of additional labeling (i.e. bottle labels, topserts, folding cartons, etc.) as needed. Issues additional computer generated labeling (i.e. bottle labels, carton labels, etc.) as needed. Understands and performs the task of returning unused labeling to inventory. Understands the inventory and planning systems in BPCS. Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA. Works and communicates effectively in a team environment. Continuous improvement focused and quality oriented as such is expected to participate in related activities and events. Promotes and adheres to safety requirements. Communicates any issues to the oncoming shift. Completes all assigned tasks and documentation according to standard. Performs other duties as assigned by supervision or as required by the position.
Tech II - Must be willing and able to perform all level I functions of the Quality Operations Area in addition to:
Process/release and/or issue and return all labeling based on packaging schedules. May prepare SOP/Form revisions as needed. Performs trending analysis to identify opportunities for improvement. Determines proper containment and or inspection actions when necessary. Communicates any issues to the oncoming shift by preparing and performing QA shift turnover. Uses Trackwise for exceptions, CAPAs, change controls and DMS. Promotes effective working relationships and communication in a team environment. Conducts training with others within the department.
Tech II - Must be willing and able to perform all level I functions of the Labeling Area in addition to:
Reviews less complicated batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP's prior to final product release. May prepare SOP/Form revisions as needed. Performs trending analysis to identify opportunities for improvement. Determines proper containment and or inspection actions when necessary. Communicates any issues to the oncoming shift by preparing and performing QA shift turnover. Initiates exceptions/investigations and assist Compliance Engineers in initiating exception/investigations for quality issues that require additional investigation. Uses Trackwise for exceptions, CAPAs, change controls and DMS. Promotes effective working relationships and communication in a team environment. Conducts training with others within the department.
