QA Inspector III

Job Title: QA Inspector III
Job Location: Medina, NY
Duration: 6 Months+(Possibility of extension)
Shift: 100% onsite –M-F: 5:30am - 4:30pm / OT as needed
Payrate: $26.75/hr on w2

ESSENTIAL FUNCTIONS:

• Perform inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules, either on paper or in the electronic Manufacturing Execution System (Camstar), to ensure all test procedures are completed and release specifications meet requirements for final acceptance and release.
• Inspect pumps and wireless battery modules to ensure all visual requirements, including approved labeling, are met prior to release.
• Approve release of pumps and wireless battery modules in the appropriate ERP systems (JDE B4ONE, JDE GME), as applicable.
• Verify there are no open nonconformances associated with pumps or wireless battery modules in the approved tracking system.
• Review device history logs within pumps to ensure final testing has been completed according to applicable procedures.
• Accurately document all failing observations using the rework form in Camstar or the nonconformance system, as applicable.
• Disposition rework activities for nonconformances and complete electronic approval and closure processes in the approved system.
• Ensure process control and maintenance procedures are followed.
• Identify out-of-compliance or out-of-tolerance conditions and take appropriate action.
• Inspect service parts and approve release of parts.
• Assist in identifying and containing nonconforming products on the floor for internal investigations and holds.
• Perform other duties as assigned.

 
QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED:

• Knowledge and practical experience with:
  • Measurement equipment
  • cGMP documentation and FDA requirements
  • Basic ESD requirements
  • Computer-based programs
  • Data entry and spreadsheet applications
• Ability to perform repetitive hand and finger movements.
• Strong attention to detail and accuracy is required.
• Good communication skills.
• Ability to work flexible hours and overtime on short notice.
• Ability to visually inspect and identify particulate/foreign matter and distinguish colors as required by FDA Current Good Manufacturing Practices (cGMP).

 
EDUCATION/EXPERIENCE REQUIRED:

• High school diploma or GED required.
• Experience in pharmaceutical or biotech industry preferred.
• Familiarity with cGMP and FDA requirements required.

 
PHYSICAL DEMANDS:

• Must be able to sit for most of the workday.
• Must be able to stand or walk for long periods.
• Good hand-eye coordination and dexterity required.
• Must be able to lift and carry up to 25 pounds.
• Must be able to push and pull a maximum force of 5 pounds over 4 feet.

 
WORK ENVIRONMENT:
This role is in a manufacturing environment regulated by the FDA and other quality systems to protect product integrity. Requirements include, but are not limited to:

• Wearing a static protective smock at all times in the work area.
• Wearing a grounded wrist strap and connecting it to the workstation at ESD-sensitive stations.
• Working in close proximity to other employees.
• Working in a temperature- and humidity-controlled environment.

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