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Quality Assurance Tech IIEndo Pharmaceuticals • United States
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Quality Assurance Tech II

Endo Pharmaceuticals
  • US
    United States
  • US
    United States
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Über

Quality Operations Area – Tech I (In-Process Batch Records Meet Compliance Requirements)
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. 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. Minimum Requirements Education: High School Education required. BS or BA preferred but extensive directly related experience could be considered. Experience: Tech I: Generally 2-4 years of related experience to perform the essential functions of the position within quality and quantity standards. Tech II: 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 Tech III: 3-6 years of related experience. Working knowledge of chemistry required with ability to perform simple trouble shooting. Preferred Skills/Qualifications: 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. 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. Other Skills/Competencies: Basic computer skills including Word, Excel and database software. Working Conditions: Location: Hobart, NY-Facility Hours: Monday – Friday 4:00pm to 2:15am Must have the ability to work overtime when needed. Pay Transparency: The expected base pay range for this position is $ 42,319.00 - $67,710.00. Please note that base pay offered may vary depending on factors including job-related knowledge, skills and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion. Relocation Assistance will not be considered for the ideal candidate. This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship needs. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees
  • United States

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  • English
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