Job Details

GMP Aseptic Cleaning Technician

OBJECTIVE
The objective of the GMP Cleaning Technician is to ensure that all Standard Operating Procedures (SOPs) are followed and that all cleaning, disinfecting and documentation expectations adhere to the facility Good Manufacturing Practices (GMP) and Good Documentation practices (GDP), all training requirements are maintained at a status of “current” and that all facility requests for special tasks are accomplished.
MINIMUM QUALIFICATIONS

• The ability to read and understand all revisions of applicable facility assigned SOPs, policies and procedures.
• The ability to work flexible hours including holidays, weekends, overtime and special assignments
• The ability to lift 40 lbs and stand for extended periods.
• Complete all training requirements for specific work areas.
• The ability to write English with good handwriting techniques and limited errors.

PREFERRED QUALIFICATIONS

• Previous Aseptic cleaning experience.
• Familiarity in pharmaceuticals, bio-research, semiconductor, medical device manufacturing cleanroom facilities.
• High School/GED preferred.
• Higher education preferred in consideration for advancement.

ESSENTIAL JOB DUTIES

• Cleaning technicians must understand and be able to mix chemicals properly and understand the dwell time for all chemicals.
• Apply chemicals to floors, ceilings, walls, fixtures in conjunction with the proper cleaning equipment such as Mops, cloths, sponges, etc.
• Sweep and mop tile floors.
• Dust horizontal surfaces.
• Clean glass doors and windows.
• Wipe clean all ledges, sills, and doors.
• Comply with the training requests to stay up to date.
• Be able to accurately make handwritten entries in facility log books

ESSENTIAL SAFETY

• Safety is of utmost importance: Hot Water for Injection (HWFI) and Water for Injection (WFI) are hot lines raised to steam levels each night. Aseptic Cleaners must use caution and wear appropriate Personal Protective Equipment (PPE) such as safety shoes, safety glasses, breathing masks, rubber gloves around and proper clothing for the specific area in addition to cleanroom gowning.
• Vacuum cleaners and mop buckets are extremely heavy when full, so the use of proper lifting techniques for emptying must be followed.
• Walking surfaces may be wet, so caution and situational awareness must always be used.
• Work safely and notify your manager of potential safety hazards and near misses.
• Perform injury report investigations and near misses for your department. Meet with the Customer’s safety representative as required. Notify your manager of potential safety hazards and near misses.

OTHER JOB DUTIES

• Buff, completely strip, machine scrub and (or) refinish tile floors.
• Become cross-trained as requested.
• Ensure that all training deviation corrections are followed.
• Ensure that you are following the dress code according to policy.
• Review Deviations and work with Manager or Compliance management to investigate.
• Review all GMP documentation for entry errors and initiate correction process immediately to ensure corrections are made no later than 24 hours after the entry.
• Participate in GMP documentation error improvements.
• Log-in and log-out for work hours.
• Take breaks and lunch in the appropriate area. Check in and out for lunch.

Any other duties as requested by the company.