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Job Description
Position Summary The Production Technician supports daily operations within the sterile compounding and production areas by assisting with material staging, cleaning activities, product handling, packaging, and classified area support. This role is essential in maintaining workflow efficiency, cleanliness, and compliance within the facility. The technician will also assist production fillers and compounding personnel with cleaning room operations during active production, including preparation, sanitation, organization of materials, and environmental upkeep of classified spaces. All duties must be performed in accordance with Company policies and procedures, current Good Manufacturing Practices (cGMP), USP standards, and applicable state and federal regulations governing sterile compounding operations.
Schedule:
Monday through Friday 8am -4:30 pm with overtime and weekend work as required. Essential Duties and Responsibilities Responsibilities include, but are not limited to: Prepare, clean, sanitize, and transfer materials, components, and supplies into classified compounding areas according to approved procedures. Support filling and production personnel during manufacturing operations by assisting with cleaning room activities and maintaining organized production areas. Perform routine cleaning and disinfection of classified production environments, including ISO-7 and ISO-8 areas, in accordance with SOPs. Organize production kits, staging materials, and facility supplies utilized during sterile compounding operations. Transfer finished products from classified production areas to post-production for inspection, labeling, packaging, and release preparation. Package, label, and box finished goods for shipment or storage. Maintain cleanliness, organization, and inventory flow throughout production and warehouse support areas. Follow all gowning and aseptic practices while working within sterile manufacturing environments. Accurately complete documentation in compliance with Good Documentation Practices (GDP). Assist with additional operational or facility support tasks as assigned. Minimum Qualifications Knowledge or understanding of cGMP regulations, including 21 CFR Part 210, 21 CFR Part 211, and USP standards preferred. Strong attention to detail and commitment to cleanliness and compliance. Ability to read, understand, and follow standard operating procedures (SOPs), batch records, and work instructions. Effective verbal and written communication skills. Ability to work independently and collaboratively in a team environment. Strong organizational and multitasking abilities in a fast-paced production setting. Ability to apply critical thinking and follow instructions accurately. Comfortable working in sterile manufacturing environments while fully gowned in cleanroom attire, including bunny suits, masks, gloves, and goggles. Flexibility to work evenings, weekends, or overtime as needed. Education and Experience High School Diploma or GED required. Previous experience in a cGMP, pharmaceutical, healthcare, manufacturing, or sterile compounding environment preferred, but not required. Physical Requirements Work may be performed in classified cleanroom environments, production areas, packaging areas, and warehouse spaces. Frequent standing and walking throughout shifts. Ability to lift and/or move up to 25 pounds regularly and up to 50 pounds occasionally. Ability to work extended periods while wearing required cleanroom gowning and personal protective equipment (PPE). Exposure to cleaning and sanitizing agents, pharmaceutical materials, and production equipment.
Job Type:
Full-time Pay:
$16.83 - $18.00 per hour
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance Application Question(s): Do you have Knowledge of cGMP regulations as it pertains to 21 CFR 210, 21 CFR 211, and USP standards? Do youhave Knowledge of Good Documentation Practices? Are you Able to work a full shift with bunny suit garb and goggles in a sterile environment? Are you able to work weekends as required? Ability to
