Quality Assurance Tech II

Endo•Hobart, NY

2d•Onsite

About The Position

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 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 III - Must be willing and able to perform all level I & II functions of the Quality Operations Area in addition to: Maintain various reports for supervisors and or managers. Attend meetings to report out on any release concerns. Process/release, issue and return all labeling based on packaging schedules. Follow-up on incidents to ensure resolution to allow folders to release to the next stage. Performs all requirements for final product disposition. Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions. Drives and participates in continuous improvement and quality initiatives. Investigates problems related to complaints. Prepare and perform QA shift turnover. 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. Tech III - Must be willing and able to perform all level I & II functions of the Labeling Area in addition to: Maintain various reports for supervisors and or managers. Attend meetings to report out on any release concerns. Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release. Follow-up on incidents to ensure resolution to allow folders to release to the next stage. Performs all requirements for final product release. Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions. Drives and participates in continuous improvement and quality initiatives. Investigates problems related to complaints. Prepare and perform QA shift turnover.

Requirements

High School Education required. BS or BA preferred but extensive directly related experience could be considered.
Minimum 2-4 years of experience in a cGMP facility and related experience to perform the essential functions of the position within quality and quantity standards
Basic computer skills including Word, Excel and database software.
Continuous improvement focused and quality oriented as such is expected to participate in and lead related activities and events.
Works and communicates effectively in a team environment.
Understanding of documentation and processes for production/packaging.
Thorough understanding of manufacturing instructions and SOP’s.
Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats.
Attention to detail and accuracy.

Nice To Haves

Ability to use Trackwise for exceptions, CAPAs, change controls and DMS.
Ability to log and complete AQL samples.
Perform mathematical functions of medium complexity: add, subtract, multiply and divide all units of measure, including metric.
Ability to identify and address problems involving standardized situations.
Working knowledge of chemistry required with ability to perform simple trouble shooting.

Responsibilities

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.
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.