Production Operator

Key Responsibilities: Operate and monitor manufacturing equipment safely and efficiently in accordance with Standard Operating Procedures (SOPs), batch records, and established production requirements. Perform in-process inspections, measurements, and quality checks to ensure products meet established record production, quality, and process information in accordance with Good Documentation Practices (GDP).Identify, document, and communicate deviations, defects, non-conformances, and other production or quality concerns. Maintain clean, organized, and compliant equipment and work areas in accordance with Good Manufacturing Practices (GMP).Support equipment setup, line clearance, cleaning, and changeover activities while minimizing downtime and maintaining product quality. Work collaboratively with Production, Quality Assurance, and Maintenance teams to resolve issues and maintain efficient all applicable health, safety, and environmental procedures and properly use required Personal Protective Equipment (PPE).Complete required training, including Master Control training, and maintain all necessary qualifications and and work toward established production goals and Key Performance Indicators (KPIs).Maintain a high level of attention to detail and accountability while working in a fast-paced, regulated manufacturing environment. Safely operate powered industrial trucks, including forklifts, when required and appropriately trained. Assist with material movement and other manufacturing activities as needed. Participate in continuous improvement initiatives and cross-functional activities that support departmental and business objectives. Perform other duties and responsibilities as assigned.

Required Qualifications: High school diploma or General Educational Development (GED) equivalent required. Technical or vocational training preferred. Previous manufacturing experience preferred, particularly within a regulated industry such as pharmaceutical, biotechnology, medical products, food, or similar manufacturing environments. Strong attention to detail and commitment to quality. Basic computer and mathematical skills. Ability to read, understand, and follow written work instructions, batch records, and quality knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and workplace safety requirements. Clear and effective written and verbal communication skills. Forklift experience preferred; ability to safely operate powered industrial trucks following required training and to work collaboratively with Production, Quality Assurance, Maintenance, and other cross-functional teams.

Schedule & Availability: Ability to work an assigned first, second, or third shift. Weekend availability may be required based on production needs. Ability to work overtime as required to support production schedules and business needs. Standard shift length is approximately 8 hours.

Physical Requirements: This position requires the ability to perform hands-on manufacturing activities for extended periods.

Physical requirements include: Ability to stand and walk for extended periods. Frequently move throughout the manufacturing area to perform assigned tasks. Frequently use hands, wrists, and fingers to perform repetitive motions and operate equipment. Frequently communicate with coworkers and other team members. Frequently operate manufacturing machinery and power tools. Regularly move, adjust, or handle objects weighing up to 25 pounds. Occasionally lift or move objects weighing up to 40 pounds without assistance. Occasionally operate motor vehicles or heavy equipment, including powered industrial trucks, when trained and authorized. Ability to climb and descend ladders, stairs, ramps, scaffolding, or similar structures as required. Ability to work in various manufacturing environments and positions while performing assigned tasks. Ability to assess the accuracy, quality, neatness, and completeness of assigned work.

Work Environment: The Production Operator works in a manufacturing environment that may include: Continuous exposure to machinery and production equipment. Noisy work environments. Occasional exposure to low or high exposure to hazardous conditions associated with manufacturing exposure to areas with limited around powered industrial trucks and other manufacturing equipment. Outdoor exposure is not expected as a regular part of the position. Employees are expected to follow all applicable safety procedures and use required Personal Protective Equipment (PPE) when performing job duties.

Quality, Safety & Compliance: Quality and safety are essential responsibilities of this position. The Production Operator is expected to consistently follow established manufacturing procedures, accurately document work performed, maintain equipment and work areas, and immediately communicate any safety, quality, equipment, or process concerns. The Production Operator must maintain compliance with applicable Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), batch records, safety requirements, and other applicable regulations and company procedures.