• Learn all the Production Operator roles, responsibilities, and SOPs specific to each area and equipment in the facility to provide support
• Facilitate the needs of Production Operators to ensure maximum productivity
• Ensure all required batch records and forms are completed in an accurate and timely manner
• Ensure all assigned equipment is being operated in a safe, productive, and in accordance with the production schedule
• Ensure products in assigned area are produced according to the batch record and specifications
• Ensure all operators are entering the correct data input for the VORNE system in all production areas to monitor the equipment overall efficiency
• Ensure assigned equipment and rooms are cleaned according to SOPs guidelines
• Adherent to company rules and safe work practices
• Maintain a clean and organized work area

• Working knowledge of Good Manufacturing Practices (GMPs) in a regulated industry
• Strong organizational and recordkeeping skills with excellent attention to detail
• Ability to prioritize multiple tasks in a fast-paced environment
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
• Clear written and verbal communication skills
• Ability to work independently while collaborating effectively with cross-functional teams
• Leadership Skills - Must have strong leadership skills and the ability to direct, organize and motivate a team. Must be proactive, detail oriented and focused on Quality. Will drive accountability with team by ensuring each person understands what is expected from them
• Communication Skills - Must be able to read and comprehend simple instructions, short correspondance and memos. Must be able to write simple correspondance. Must be able to effectively present information to employees at all levels
• Mathmatical Skills - Must have the ability to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals
• Reasoning Ability - Must have the ability to apply common sense understanding to carry out detailed written or oral instructions. Must have the ability to handle problems involving a few variables in standardized situations
• Physical Demands - The physical demands described here are representative of those that must be met to successfully perform the major accountabilities of this job. Reasonable accomodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required to stand, walk, use hands and fingers, handle or feel, reach with hands and arms, climb or balance and stoop, kneel, crouch or crawl. The employee is frequently required to talk or hear. The employee is occasionally required to sit. The employee must regularly lift and or move up to 75 pounds unassisted. Specific vision abilities required by this job include the ability to focus depending on the situation
• Mechanical aptitude - Employee must be able to learn to operate, maintain and adjust assigned equipment
• Dependability - Employee must arrive on time for assigned shift. Must have a valid drivers license
• Forklift Training - Must be able to learn how to operate a forklift safely and efficiently
• Respirator use - Employee must be able to wear a respirator depending on the situation

• Minimum - High School Diploma
• Preferred - Associate's or Bachelor's degree in a scientific, technical, or business discipline

• 1-2 years of work experience in a GMP-regulated environment (dietary supplements, pharmaceutical, food, or medical device preferred)

• Managing a multi-operational in a manufacturing environment on the off-shift (after 10pm to 7am)
• Experience with using ERP/MRP systems and performance management tools
• Familiarity with FDA 21 CFR Part 111 (dietary supplements) or Part 210/211 (pharmaceuticals)
• Exposure to audit preparation or participation

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