Manufacturing Visual Inspection

2 weeks ago


Fremont, CA, United States Fladger Associates Full time

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
Skills:
  • 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


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