Job Description

The Aseptic Technician will prepare, mix, and assemble finished sterile products with a focus on patient safety and quality. This employee will ensure that the clean room maintains safety and cleanliness standards and that all standard operating procedures are followed with 100% accuracy and documented thoroughly.

Essential Job Functions:

Maintain a sterile environment in the cleanroom including, but not limited to, garbing, cleaning, and working according to CGMP practices or guidelines. Clean the equipment in the clean room daily and ensure equipment validations are up to date. Take inventory in the clean room to identify components needed to fill production batches, as scheduled. Ensure all components entering the clean room are sterile. Coordinate and communicate with compounding to obtain supplies needed to turn products; communicate within the clean room, from room to room. Document batch records, measurements of air in the room, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs. Prepare and sterilize components/vials for appropriate solutions; sterilize solutions and fill into specified containers. Validate that garbing standards have been followed on a semi-annual basis. Complete 3 consecutive fills with a set minimum of syringes and vials that is established by the quality department in an established time frame and in the most difficult operating conditions to pass validation every 6 months. Follow standard operating procedures to package sterile products in their final container closure. Use the appropriate process to establish sterility on products received via pass-through from compounding. Perform general cleaning duties that include, but are not limited to, sweeping, mopping, sterilizing, taking out the trash, and wiping down surfaces. All other duties as assigned.

Preferred Talents:

Ability to work with others in a positive and professional manger with teamwork. Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted. Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique. Ability to prioritize and plan work activities. Manage time effectively and adapts quickly to changing priorities. Ability to handle multiple tasks and organize resources to ensure work is completed on time.

Qualifications:

High school diploma or equivalent. Previous experience in a hospital IV room or manufacturing environment, preferred. Knowledge of clean room procedures, required. Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, preferred but not required. Must pass aseptic technique validation three consecutive times before working in the clean room.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand for the duration of the shift, walk, use hands to handle or feel, reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl, and talk or hear. The employee must regularly lift and/or move up to 25 pounds and occasionally lift and/or push or pull more than 50 pounds.

Working Environment:

While performing the duties of this job, the employee will work in mostly indoor environments, but will be occasionally exposed to outside weather conditions. The employee may be exposed to chemicals, odors, dust, cold, heat and fumes in the work environment. The noise level in the work environment is usually moderate.

Must wear aseptic gown and/or other required PPE, as required.

Staska Pharmaceuticals is an Equal Opportunity Employer

Job Type: Full-time

Pay: From $20.00 per hour

Benefits:

401(k) Health insurance Paid time off
Work Location: In person