- Understands production scheduling and work flow, material control, quality, Good Manufacturing Practices, component ID and safety as part of job duties. Utilizes computers to manage the weekly schedule, move manufacturing equipment/material, interface with equipment or input/track quality data. Identifies and reports problems, generally requiring minimal analysis.
- Makes decisions to terminate processes or requires management intervention where personal safety or product quality may be jeopardized. Monitors machinery, equipment, and operator activities ensuring that products are manufactured according to specifications. Monitors operation of machinery or equipment to detect malfunctions, the need for minor adjustments or the need for maintenance.
- Ensures equipment set ups, adjustments, cleans, and change overs are completed accurately and in a timely manner. Understands written and electronic manufacturing procedures and initiates changes to those documents and instructions as required to maintain their accuracy and effectiveness.
- Communicates in a clear, timely manner to coworkers, supervisors, or customers one-on-one or in a small group. Provides training and direction to Operators, Sr. Operators, and Group Leaders. Performs verifications and documentation reviews to ensure all documents are filled out correctly.
- Demonstrates knowledge of the applicable safety standards and practices required in the manufacture of products through personal work habits. Schedules and supports maintenance activity within the production area. Effectively works to resolve problems within functional area. Supports product development efforts and provides technical information as necessary.
- Provides guidance, information and answers to technical and non-technical questions in a courteous and tactful manner.
- High School Diploma or GED required.
- At least 5 years of experience in a manufacturing and/or mechanical operations environment is required.
- Knowledge of basic math, strong leadership and interpersonal skills and the capability to effectively employ advanced computer skills.
- Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP) specifically, knowledge of regulations and standards affecting pharmaceutical manufacturing.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced