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