Job Information
Mallinckrodt Pharmaceuticals Quality Assurance Tech II Second Shift in United States
Job Title
Quality Assurance Tech II Second Shift
Requisition
JR000014334 Quality Assurance Tech II Second Shift (Open)
Location
Hobart, NY
Additional Locations
Job Description Summary
Performs review of medium complexity for all manufacturing and packaging batch records at appropriate stages in order to ensure accuracy and completeness and to reconcile at end of run. Processes and Issues labeling for the packaging of products to support the production schedules. Ensures quality procedures are followed and evaluates the organization's products, materials, and facilities for compliance. Determines if current methods and techniques result in meeting reliability standards or require modification. Takes appropriate action to correct any identified issues. Performs audits of systems and triages of product related events to evaluate and contain impact. Assists with production compliance and labeling activities as required. Depending on the department to which the incumbent reports some of the functions listed may not be applicable.
Job Description
Shift: 4:00pm - 12:30am
Compensation Range: $46,000.00 - $55,000.00
Shift Differential: Additional $2.00 / hour
Sign-On Bonus: $3,500.00
Benefits available from day one
3% automatic 401K match
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.
Labeling Area (Tech I)
Processes/releases, issues and returns all labeling based on packaging schedules. Enters SCARs for vendor defects noted during processing of labeling. Ensures timely Issuances of computer generated and commercial labeling to the Packaging department. 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. Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change. Processes labeling returns and rejections. Reviews equipment records and logs for completeness and accuracy when required. Coordinates with operators, supervisors, team leaders, and QA to obtain information/line status. Assists in training operators on the labeling process. Ensures timely flow of records and product to next stage. Understands the inventory and planning systems in BPCS. Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA. Completes all assigned tasks and documentation according to standard. 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 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.
At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.
Invest in your own career with Mallinckrodt and let’s do something dynamic together.
Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
Additional information on Mallinckrodt’s hiring practices may be found by clicking