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      Role Summary
 Manufacturing Operator I/II - Bulk (2nd shift)
 
 Responsibilities
 
  - Operate manufacturing equipment to achieve production goals.
 
  - Setup, operate, monitor & control equipment, systems & processes
 
  - Clean & sanitize manufacturing, filling & packaging rooms & equipment per SOPs
 
  - Execute production schedule to achieve production goals
 
  - Handle labeling & components correctly; transferring, counting, FIFO, returns, etc.
 
  - Participate actively in & support event response
 
  - Read & follow SOPs, job instructions & other documents to ensure compliance
 
  - Identify, report & resolve quality issues
 
  - Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
 
  - Record/review production data in BPR & associated forms
 
  - Follow all safety & environmental requirements in the performance of duties
 
  - Other duties as assigned
 
 
 
 Qualifications
 
  - High School Diploma or Equivalent required
 
  - Associate’s Degree or Bioworks Certification preferred
 
  - Minimum of one (1) year of experience in pharmaceutical solid dose manufacturing or other FDA regulated industry preferred
 
  - Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required
 
  - Computer literacy including use of Microsoft Office suite programs required
 
  - Basic mechanical skills preferred
 
 
 
 Education
 
  - High School Diploma or Equivalent required
 
  - Associate’s Degree or Bioworks Certification preferred
 
 
 
 Additional Requirements
 
  - Physical requirements include handling up to 33 pounds, prolonged standing, potential exposure to cold environments, and other site-specific conditions; must be able to work in loud environments with hearing protection