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Responsibilities:

• Excellent employment opportunity for a Manufacturing Visual Inspection in the Fremont, CA area.
• Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• Executes independently with adequate training, complex fundamental operations as visual inspection, advance visual inspection, palletizing, cleaning, inspection hood prep for operations, BioMES Operations and Exceptions.
• Performs internal support duties including assisting drug product filling and packaging.
• Executes independently with adequate training fundamental operations: -Logistics Coordination, Batch record executions Equipment use logs -Work order initiation and tracking -Support Projects -Support Creation/Maintain Training Kits Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains production areas according to predefined standards (5s).
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Contributes to Quality activities such as supporting investigations, corrective actions and area walk throughs.
  

Experience:

• High School Diploma and minimum 1-year work experience in GMP regulated industry.
• Associates/Bachelor's Degree or Biotechnology Vocational training preferred.
• 1 or more year of experience in cGMP regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and manufacturing execution systems (MES).
• Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Must be able to read and see clearly.
• Employees requires to participate and have acceptable result from vision testing including color blindness.
• Duties of this position may require the incumbent to exert some physical effort.
• Lifting requirements may vary dependent of the drug product manufacturing visual inspection area activity.
• Weight is typically no more than 25 pounds.
• Required Skills: DETAIL ORIENTED, GMP, LOGISTICS, CGMP, BIOTECHNOLOGY
  Additional Skills: OPERATIONS, PACKAGING, SOPS, TRAINING, VISUAL INSPECTION, VOCATIONAL TRAINING, BATCH RECORD, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS, PALLETIZING, SAFETY STANDARDS