Quality Assurance Tech II

About the role

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.
• 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.

Responsibilities

• Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release.
• Covers all Level I functions and additional responsibilities for Tech II and Tech III positions.
• 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.
• Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA.
• Works and communicates effectively in a team environment.
• Promotes and adheres to safety requirements.
• Completes all assigned tasks and documentation according to standard.
• Performs other duties as assigned by supervision or as required by the position.

Requirements

• Minimum Requirements: 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.
• Preferred Skills/Qualifications: 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.

Qualifications

• Working knowledge of chemistry required with ability to perform simple trouble shooting.
• 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.
• Attention to detail and accuracy.