Technician I, Manufacturing QA (3rd Shift, Monday Night - Friday Night)

Role Summary

Technician I, Manufacturing QA on 3rd shift (Monday night – Friday night) responsible for visual inspection of finished and in-process materials, defect classification, and test disposition to ensure products meet quality limits according to FDA regulations. This role includes documenting inspection results, supporting quality sampling, and collaborating with cross-functional teams to drive quality improvements.

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.

Qualifications

• High School Diploma required.
• 1 to 2 years of experience conducting quality inspections in a pharmaceutical setting is preferred.
• 1-2 years of experience in a manufacturing/packaging environment is preferred.
• Able to comprehend and contribute to and supporting 5S, safety and compliance activities/walk-throughs for the operation.
• Knowledge of cGMP requirements and procedures affecting pharmaceutical products is preferred.
• Basic computer skills and ability to learn new programs and applications as required.
• Requires standing up to 8-12 hours per day and lifting up to 25 pounds.
• Additional hours may be required to support the needs of the business.
• Able to communicate clearly and effectively.

Skills

• Clear communication
• Basic computer proficiency
• Attention to detail
• Ability to learn new programs and systems

Additional Requirements

• This is a 3rd Shift position: Monday - Friday Night, Work hours: 11pm - 7am
• Able to stand for long periods and lift up to 25 pounds