Fill Finish

Responsibilities:

• Excellent employment opportunity for a Fill Finish in the Fremont CA area.
• Ability to independently and accurately prepare all assigned records calculations and documentation.
• Demonstrated ability to independently and properly handle and dispose of hazardous waste.
• Ability to read and follow schedules procedures and documents.
  Demonstrated knowledge of safety precautions and procedures.
• Will be required to assist in training other employees in an area of responsibility as assigned.
• Assist staff in developing new procedures and methods or improving old ones.
• Ability to practice aseptic technique independently.
• Ability to perform media fills with (process simulation testing) with passing results per applicable SOP.
• Ability to perform clean room gowning and pass clean room garment validation consecutively.
• Ability to independently prepare disinfectants and sanitizing solutions.
• Ability to independently clean and sanitize production equipment rooms and areas.
• Demonstrated knowledge of an aseptic operation and the relationship of laminar flow systems and environmental monitoring.
• Ability to assist in performing environmental monitoring such as but not limited to independently placing settling plates and air sampling.
• Ability to use basic hand tools.
• Ability to independently setup operate maintain and troubleshoot steam sterilizers capping machines stoppering machines bottle washers sterilizing tunnels equipment washing machines sterile filtration equipment L bar sealers/Bundler vision systems inkjets vacuum check equipment as needed.
• Ability to wear a respirator if required of the job no pulmonary restrictions.
• Ability to independently use and understand computer assisted data entry.
• Ability to independently perform sterile filtration.
• Ability to aseptically gather and transfer samples for QC testing.
• Ability to independently perform filter integrity and prepare accurate documentation
  

Experience:

• High School Diploma or GED
• Demonstrated ability to lift fifty (50) pounds.
• Demonstrated knowledge of Federal State and International regulations such as cGMP USDA DOT EPA OSHA as they pertain to the employees work.
• Demonstrated knowledge of corporate guidelines and Policies related to the employees work.
• Demonstrated knowledge of Standard Operating Procedures (SOPs) related to the employees work.
• Demonstrated knowledge of Material Safety Data Sheets (MSDSs) safety procedures and hazardous materials procedures.
• Demonstrated knowledge of aseptic processing procedures related to the employees work.
• Demonstrated knowledge of team process and leadership principles.
• Demonstrated knowledge of appropriate processes and theory related to the employees work.
• Demonstrated knowledge of documentation related to the employees work.
• Demonstrated knowledge of equipment as defined in Duties Additional education and/or equivalent experience.
• Successful completion of National Career Readiness Work Keys assessment.
• Knowledge of Traffic Patterns.
• Knowledge of or evidence of working with BPE Methods.
• Understanding of Basic GMP/Documentation practices.
• Demonstrated ability and understanding of safe working habits.
• Required Skills: ENVIRONMENTAL MONITORING FILTRATION ASEPTIC PROCESSING VISION SYSTEMS ASEPTIC TECHNIQUE
• Additional Skills: ASEPTIC DOCUMENTATION STERILE DOT GMP DATA ENTRY SOP EPA CGMP OSHA SOPS QC TESTING CLEAN ROOM AIR SAMPLING USDA PROCESS SIMULATION HAND TOOLS VACUUM LOCKOUT/TAGOUT