Job Details

Responsibilities:

• Excellent employment opportunity for a MFG Sr Associate-Filling & Visual Inspection in the Fremont, CA area.
• Contract - 6-36 months
• 3rd SHIFT: Sunday-Thursday, 10:00PM to 6:30AM, 15% Shift Differential
• 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 techniques 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 set-up, 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 GE
• Experience with GMP production
• Direct & relevant experience with Aseptic processing/filling.
• Document Revision
• Deviation Management
• Production coordination/scheduling
• Understanding of Basic GMP/Documentation practices.
• Ability and understanding of safe working habits.
• Ability to work in a team environment.

Demonstrated knowledge of:

• Federal, State, and international regulations, such as cGMP, USDA, DOT, EPA, OSHA
• Corporate guidelines and Policies related to the employee's work.
• Standard Operating Procedures (SOPs)
• Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures.
• Aseptic processing procedures related to the employee's work.
• Team process and leadership principles.
• Appropriate processes and theory related to the employee's work.
• Documentation related to the employee's work.
• Equipment as defined in Duties Additional education and/or equivalent experience.
• Successful completion of National Career Readiness Work Keys assessment.
• Traffic Patterns.
• Working with BPE Methods.