Job description

Responsibilities:

· Excellent 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 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:

· 1 year or GMP or other Manufacturing experience High School Diploma or GED

· Demonstrated ability to lift 50lbs

· Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employee’s work.

· Demonstrated knowledge of corporate guidelines and Policies related to the employee’s work.

· Demonstrated knowledge of Standard Operating Procedures (SOPs) related to the employee’s work.

· Demonstrated knowledge of Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures.

· Demonstrated knowledge of aseptic processing procedures related to the employee’s work.

· Demonstrated knowledge of team process and leadership principles.

· Demonstrated knowledge of appropriate processes and theory related to the employee’s work.

· Demonstrated knowledge of documentation related to the employee’s 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.

· Ability to work in a team environment.

· Schedule: Monday to Friday, 8:00AM – 4:30PM

Required Skills: ASEPTIC PROCESSING, ASEPTIC TECHNIQUE, CGMP, AIR SAMPLING, ASEPTIC

Job Type: Contract

Salary: $15.00 - $25.80 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Fremont, CA 94536: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Required)
• CGMP: 1 year (Required)
• Filing: 1 year (Required)

Work Location: One location

Speak with the employer
+91 +13023093988

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