Technician I, Manufacturing QA (1st shift 7am-3pm)

Role Summary

Technician I, Manufacturing QA performs visual inspection of finished and in-process materials, classifies defects, and determines test disposition to ensure products meet FDA-regulated quality limits. The role also records inspection results, ensures Good Documentation Practice, and supports quality sampling across multiple production lines. This is a 1st Shift position: Monday - Friday, Work hours: 7am - 3pm.

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

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