Quality Assurance Tech II

Job Summary

Perform review of medium complexity for all manufacturing and packaging batch records at appropriate stages to ensure accuracy and completeness, reconcile at end of run, and manage process and issue labeling for the packaging of products to support production schedules.

• Review batch records for compliance, completeness, accuracy, and any deviations from approved manufacturing/packaging instructions and SOPs prior to final product release.
• Coordinate with operators, supervisors, team leaders, and QA to obtain corrections, missing information, and sign-offs in the batch folder.
• Assist in training operators on proper documentation and documentation practices.
• Review quality control checks during and after production and ensure timely flow of records and product to the next stage.
• Review equipment records and logs for completeness and accuracy when required.
• Maintain various reports for supervisor/manager by inputting/updating pertinent data.
• Maintain knowledge of cGMPs, current manufacturing instructions, SOPs, and prepare revisions as needed.
• Prioritize and process work according to production schedules; re‑prioritize as schedules change.
• Assist with issuance of additional labeling (e.g., bottle labels, topserts, folding cartons), including computer generated labeling, and return unused labeling to inventory.
• Understand and perform the task of returning unused labeling to inventory.
• Understand the inventory and planning systems in BPCS.
• Communicate with production/packaging operators, supervisors, warehouse compliance engineers and QA.
• Promote safety requirements and participate in continuous improvement and quality initiatives.
• Communicate any issues to the oncoming shift and complete all assigned tasks and documentation according to standard.
• Perform other duties as assigned by supervision or required by the position.

• In addition to all Tech I functions, process/release and/or issue and return all labeling based on packaging schedules.
• Prepare SOP/Form revisions as needed.
• Perform trending analysis to identify opportunities for improvement.
• Determine proper containment and/or inspection actions when necessary.
• Communicate issues to the oncoming shift by preparing and performing QA shift turnover.
• Use Trackwise for exceptions, CAPAs, change controls and DMS.
• Conduct training with others within the department.

• In addition to all Tech II functions, maintain various reports for supervisors and/or managers.
• Attend meetings to report on any release concerns.
• Follow-up on incidents to ensure resolution and allow folders to release to the next stage.
• Perform 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.
• Drive and participate in continuous improvement and quality initiatives.
• Investigate problems related to complaints and prepare and perform QA shift turnover.

• High School Education required; BS or BA preferred but extensive directly related experience may be considered.
• Tech I: 2–4 years of related experience to perform essential functions within quality and quantity standards.
• Tech II: 2–4 years of experience in a cGMP facility and related experience to perform essential functions.
• Tech III: 3–6 years of related experience and working knowledge of chemistry with ability to perform simple troubleshooting.
• 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.
• Basic computer skills including Word, Excel, and database software.
• Attention to detail and accuracy.
• Understanding of documentation and processes for production/packaging.
• Ability to communicate effectively at all organizational levels.

• Continuous improvement focused and quality oriented; participate in and lead related activities and events.
• Strong teamwork and communication skills.
• Proficiency with manufacturing instructions and…