Visual Inspection Program Lead/SME (Contract)

Location: United States; remote work is supported, with hybrid office work encouraged for hires located within a reasonable commute of a hirify.global office.

Contract duration: approximately 16 weeks (400 hours).

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Lead assessment activities for the Visual Inspection Program Enhancement workstream.
• Develop risk-based recommendations for visual inspection procedures and qualification methodologies.
• Assess particulate-control programs and defect management practices.
• Prepare supporting quality-system documentation and project deliverables.
• Strengthen visual inspection processes for sterile manufacturing operations.

Requirements

• 7 years of relevant experience.
• Experience with visual inspection and defect classification.
• Knowledge of AQL and Knapp studies.
• Experience with inspector qualification and inspection qualification.
• Experience with sterile injectables and sterile manufacturing operations.

Culture & Benefits

• Remote working is supported.
• Hybrid office collaboration is encouraged where practical.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Collaborative and entrepreneurial working environment.
• Applications are reviewed personally by the recruitment team without AI screening tools.