Aseptic Compounding Technician

JOB PURPOSE

Using company procedures and guidelines, the Aseptic Material Handler shall support the handling and processing of batch materials and equipment within Cleanroom operations.

KEY ACCOUNTABLITIES

• Regular and predictable onsite attendance and punctuality
• Directly support Cleanroom compounding/filling operations by picking and staging of batch materials for production
• Load/unload batch materials from disinfection chambers and stage or store these materials per internal SOPs
• Inspection and disinfection of batch materials and supporting materials as required
• Safely transport and transfer materials
• Demonstrate appropriate cleanroom behavior and aseptic technique
• Complete and maintain applicable logbook and batch record paperwork abiding by Good Documentation Practices (GDPs)
• Maintain gown qualification
• Escalate any and all process issues to the area supervisor or designee
• Perform thorough cleaning and disinfection of the classified areas per internal SOPs
• Maintain good hygiene prior to coming into work each day
• Perform other related duties as determined by management personnel

QUALIFICATIONS

• Minimum: H.S. Diploma or equivalent
• Preferred: Some college or a college degree is preferred

EXPERIENCE

• Minimum: One (1) year of cGMP pharmaceutical manufacturing experience
• Preferred: Cleanroom experience with training on aseptic technique is preferred

SKILLS

• Good oral and written communication skills are essential
• Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
• Ability to examine problem areas and make recommendations for corrective action
• Must be able to comprehend and follow all applicable SOPs
• Heavy continuous exertion
• Will be required to lift 5 – 40 pounds
• Must be able to stand for long periods of time
• Must be able to wear required PPE
• Must work in a cleanroom environment wearing company-issued scrubs, as well as a hood, coverall, boots, gloves, and goggles
• The noise level is moderate to loud in the cleanroom areas
• The use of sanitizing agents to clean the cleanroom areas may be moderately disagreeable

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• Paid time off
• Company holidays
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities

• Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms