Job Details

Fremont, CA

Contract Duration: 6-36 months

Rate: Negotiable

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.
• 1st Shift: Mon-Fri, 8AM-5PM

• High School Degree (Diploma or GED) + minimum 1 year work experience in GMP regulated industry
• Associates/Bachelor's degree or biotechnology vocational training preferred1 or more years 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 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.
• PHYSICAL DEMANDS:
  • Duties of this position may require the incumbent to exert some physical effort.
  • Lifting requirements may vary dependent on the drug product manufacturing visual inspection area activity. Weight is typically no more than 25 pounds.
  • Employees required to participate and have acceptable result from vision testing including color blindness.
• Required Skills:
  • BIOTECHNOLOGY
  • PACKAGING
  • VISUAL INSPECTION
  • CGMP
  • SOPS
• Additional Skills:
  • EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
  • PALLETIZING
  • SAFETY STANDARDS
  • BATCH RECORD
  • GMP
  • DETAIL-ORIENTED
  • VOCATIONAL TRAINING
  • OPERATIONS
  • LOGISTICS