Purpose.

The Manufacturing QA Technician will work in a high performing and fast-paced pharmaceutical finishing operation and performs sampling and visual inspection of both finished and in-process materials per the appropriate operating procedures and electronic batch record. Uses sophisticated programs (such as POMS and Systems, Application, Products (SAP) business software) to evaluate in-process data, which can be used to determine acceptable quality limits and product release requirements. Responsible for supporting and contributing to a quality-focused environment by motivating/influencing others and always driving for excellence within the group.

Responsibilities

• Performs visual inspection of finished and in-process materials, classifies defects, and determines test disposition for products across all value streams to ensure product meets acceptable quality limits based on FDA regulations.
• Responsible for entering in-process inspection results as required for Acceptable Quality Limits and defect recognition in manufacturing systems such as SAP, POMS and Laboratory Information Management System.
• Responsible for accurate documentation and compliance with Good Documentation Practice requirements of the tasks performed.
• Manages quality sampling across multiple production lines in accordance with the production schedule in a timely manner.
• Effectively executes assigned tasks and priorities with minimal supervision and seeks additional guidance when problems are the beyond scope of training or knowledge.
• Elevates higher level safety, quality, technical and operating issues/details in a timely manner to the appropriate group.
• Provides support for improvement opportunities in the areas of documentation, procedures, processes and equipment through cross functional team interaction.
• Collaborates with others to maintain a positive atmosphere to accomplish business objectives and fosters positive working relationships.