Temp-Manufacturing-Inspection-2nd Shfit

AlkermesWilmington, OH
Onsite

About The Position

This is a temporary position focused on inspecting Good Manufacturing Practices (GMP) vials and glass vials for defects. The role also involves performing label and packaging activities for finished products. The inspector will ensure compliance with cGMP requirements and assist in various manufacturing functions.

Requirements

  • High School diploma or equivalent
  • Organization and interpersonal Skills (Oral, Written, etc.)
  • Good Computer and Database Skills
  • Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry
  • Good math skills
  • Self-motivated
  • Good visual acuity
  • Team Oriented
  • Effective organization skills and attention to detail
  • Ability to work with minimal supervision
  • Ability to work flexible hours
  • Ability to work hands-on
  • Prolonged periods of sitting or standing
  • Periods of repetitive motion
  • Walking, squatting, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required
  • Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed
  • Employee must be able to pass a vision exam before employment and annually

Nice To Haves

  • 0-1 year experience in a sterile pharmaceutical operation preferred
  • Associate degree or higher in a science/technical discipline

Responsibilities

  • Inspect vialed product and empty glass for defects
  • Perform daily process activities in compliance with standard operating procedures (SOPs)
  • Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas
  • Assist in writing and implementing area’s process documents
  • Operate equipment in compliance with SOPs
  • Assure compliance with cGMP requirements (current good manufacturing practices)
  • Work non-routine hours as required to maintain production schedule
  • Perform label and packaging activities for finished product
  • Complete and review associated production records and daily trending
  • Train new inspectors in accordance with vial inspector certification procedures
  • Assist other manufacturing functions (Formulation, Fill, Materials) as required
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