MFG Associate – Filling & Visual Inspection

Job Description:

Job Title: MFG Associate – Filling & Visual Inspection 

Duration: 06 Month

Location: Fremont, CA 

Hours Per Day: 8.00 

Shift: 3rd SHIFT: Sunday–Thursday, 10:00PM to 6:30AM 

Shift Differential: 15% 

Duties

• 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. 

Skills

• Basic operator functions. 
• New to GMP. 
• Ability to lift fifty (50) pounds. 
• 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. 
• Understanding of Basic GMP/Documentation practices. 
• Ability and understanding of safe working habits. 
• Ability to work in a team environment. 

Education: High School diploma or GE 

Years of Experience: 2