Post Production Visual Inspection Specialist

Sobre o trabalho

The primary purpose of the Post-Production Visual Inspection Specialist would be to review and maintain current visual inspection test kits as well as establish new test kits as demand progresses.

Responsibilities

• Initiate, author and complete production protocols for the maintenance and creation of visual inspection test kits.
• Create acceptable and defect units. Conduct Point of Detection inspections for acceptability of units.
• Complete end of year review for all test kits to maintain quality of the kits.
• Maintain the defect library resources including continuous photo provisions for defect work instructions, MVA results, etc.
• Collaborate with post-production visual inspection and Quality to investigate training errors and deviations, own action items for Corrective and Preventive Actions (CAPAs). Ensure timely signoff of action items and CAPAs to enable department compliance.
• Facilitate collaborations with training, active visual inspection, manufacturing quality and management to identify test kit needs and inadequacies.
• Collaborate with Quality Compliance Team regarding internal audits and results.
• Provide quick, quality-based decisions while serving as the immediate escalation path for visual inspection staff during post-production activities.
• Support post-production continuous improvement initiatives.
• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
• Collaborate with management, supervisors and leads to author, review or revise applicable SOPs, training course plans, batch records, and other operational related documents.
• Conduct technical training for post-production manufacturing operations.
• Conduct review of visual inspection operations to ensure compliance to procedures.
• Other tasks and duties as assigned by Area Management.
• Investigate, document findings and influence assessment for deviations.
• Assist assigned functional area leads in driving problems to resolution.
  
  

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Profile/Experiences

• High school diploma or equivalent required.
• Excellent time management skills and ability to self-direct in managing concurrent requirements
• Ability to communicate with colleagues, customers, suppliers, in person, on the phone, and by written communications in a clear, straightforward, and professional manner to clearly convey priorities and need.
• Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
• Proactive, problem-solving mindset – ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.
• Skilled, flexible worker with strong people skills and an extensive background in cGMP manufacturing.
• Knowledge and experience in Current Good Manufacturing Practices (cGMP) regulations, documentation, and compliance.
• Experience in batch paperwork and processes.
• Minimum of 6 months cGMP post-production experience.
• Direct experience in processes acclimated to post-production.
  
  

O que oferecemos?

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.