Sterile Filling Technician

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Description

Corporate Statement

Nephron Outsourcing Facility is a 503B outsourcing facility dedicated to creating the highest quality compounds by maintaining current good manufacturing practices to and above the standards set by the FDA.

Position Summary: Sterile Filling Technician - ? Must Register as a Pharmacy Technician

• Prepare cleanrooms for all Filling activities.
• Sanitize and inspect all production materials.
• Maintain proper documentation of all compounding activities consistent with established GDP policies and procedures.
• Assist in inventory control and stocking of supplies.
• Must maintain a Gown certification (required to enter cleanroom)
• Learn and utilize all relevant software/technology for compounding operations.
• Assist with cleanroom cleaning and maintenance as appropriate or required.
• Constantly meet and exceed established productivity and quality standards.
• Thrives in a fast paced environment.
• Perform compounding operations consistent with established protocols, procedures, and cGMP requirements for all filling processes. (example: syringe, IV bag filling/capping in the ISO-5 Environment)
• Successfully complete a Media Fill process to qualify as a Sterile Filling Technician.
• Perform compounding operations consistent with established protocols, procedures, and cGMP requirements related to the set-up, breakdown, operation of Automated Filling equipment and IV Bag filling operations to include the setup, CIP, SIP, and Purge.
• Ability to multi-task and work independently; to prioritize and perform tasks efficiently even when under pressure or time constraint and follow-through to completion.
• Ability to interact with all levels of management.
• Performs all other duties as assigned or apparent.
  
  

Knowledge, Skills & Abilities

NOTE: The primary accountabilities and knowledge, skills and abilities are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• High School Diploma or equivalent
• Willingness to participate in training and gain other certifications as needed.
• Basic computer skills
• MUST PASS DRUG TEST
• MUST BE A TEAM PLAYER
• A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to create and contribute to an environment that values safety, people, encourages trust, teamwork, open communication, participation, learning, and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve departmental goals.
• Position requires lifting (up to 50 lbs.), vision (20/20), bending (waist to floor), climbing (on a ladder), reaching (floor to overhead), standing (40%), sitting (20%), walking (40%), gripping, talking and hearing.
• Incumbents may be required to wear safety glasses, hearing protection, bouffant, and laboratory coats and other non-specified protective equipment as necessary.
• Must be able to work 12-hour Shifts
• This is a 24/7 operation and will require weekends and/or holidays to be staffed.