Duties and Responsibilities

• Strictly follows standard operating procedures (SOP). 
• Complies with Good Manufacturing Practice (GMP). 
• Completes documentation, including logbooks, batch records, and quality records. 
• Maintains an organized, clean, and stocked production area. 
• Cleans tools, rooms, and equipment after use. 
• Weighs, measures, subdivides, and disposes of product components. 
• Safely handles and disposes of hazardous materials. 
• Operates specialized machinery to manufacture pharmaceutical products under supervision. 
• Works closely and communicates effectively with operations team. 
• Performs other related duties as assigned. 

Required skills and Abilities

• Mechanical aptitude. 
• Strong verbal and written communication skills. 
• Strong organizational skills and attention to detail. 
• Proficient in basic math. 
• Strong time management skills with ability to meet deadlines. 
• Ability to prioritize and ask for assistance to delegate tasks when appropriate. 
• Ability to focus in a fast-paced environment with shifting priorities. 
• Proficient with Microsoft Office Suite or related software. 

Education and Experience

• High School Diploma or equivalent.  
• Coursework or experience in chemistry or manufacturing field preferred.
• Operations Specialist require a minimum of 1 year of GMP experience within pharmaceutical manufacturing  

Physical Requirements

• Prolonged periods of sitting or standing while monitoring equipment. 
• Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally. 
• May require ability to work swing or weekend shift with the possibility of 12-hour shifts. 
• Must be able to wear a Tyvek suit with PAPR for extended periods of time. 
• Exposure to constant low-level equipment noise, and occasional high-level alarms. 
• Work near heat generating equipment. 
• Must be able to operate a forklift.  
• Move up and down ladders, kneel, squat, balance on one foot.  
• Move mop above head while cleaning room surfaces.