Hiring Organization / Company: Cepheid
Basic Salary: To Be Discussed
Employement Type: Full-Time
ESSENTIAL JOB RESPONSIBILITIES:
Understand and adhere to safety policies and practices
Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
Maintain dry room and cleanroom standards, practices, and housekeeping according to standard operating procedures.
Set up and operate manufacturing equipment. Monitor machines and inform Supervisor and/or Lead of problems. Clean and maintain equipment and work area as needed.
Assist Senior Operators
Use tools such as microscopes, tweezers, and other hand-held tools.
Perform in-process inspection of components and assemblies to verify quality conformance.
Recognize any minor issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors and Leads of issues and discrepancies immediately.
Report causes of process and/or documentation and assist or coordinate resolutions.
Apply company policies and procedures to complete assignments.
Conduct Shift PASSDOWN with peers
Start and end batch runs. follow production schedules
Follow acceptance criteria for equipment yield and efficiency
Email the Manufacturing Engineering group explaining any downtime problems/issues.
Perform label printing responsibilities
Prepare and verify materials to be used as issued to work orders
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Education and Experience (in years):
1-2 years of related experience
High School diploma/GED or equivalent experience
Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
Experience in FDA or Kema audits
Knowledge and skills:
Ability to read drawings.
Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
Must be a team player and able to demonstrate willingness and ability to provide assistance to co-workers.
Ability to clearly and effectively communicate with peers, supervisors, manufacturing engineers, stockroom managers and leads. Able to understand instructions and batch records written and spoken in English.
Effective verbal and written communication skills
Ability to pay close attention to detail.
Basic Computer Skills
Ability to solve basic math problems
Able to identify each station of the machinery.
Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.
Ability to work directly with, handle or come into contact with chemicals or reagents.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Job Location Information:
Location: Sunnyvale, Ca 94089
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