Manufacturing Specialist, Quality Assurance (Pharmaceuticals)

TL;DR

Manufacturing Specialist, Quality Assurance (Pharmaceuticals): Ensuring compliance and quality standards in a pharmaceutical manufacturing environment with an accent on production record review and area clearance. Focus on conducting root cause analysis for investigations and maintaining FDA regulatory compliance.

Location: Onsite in Bend, Oregon, USA

Company

hirify.global is a global leader in life sciences, operating across five continents to manufacture breakthrough medicines.

What you will do

• Perform area clearance activities to ensure production readiness and compliance.
• Apply and maintain correct product status labeling, including QA hold and rejected materials.
• Review production records for accuracy and compliance with quality standards.
• Support quality systems implementation and continuous improvement initiatives.
• Monitor product compliance throughout the manufacturing process.
• Assist with investigations, including root cause analysis and corrective actions.

Requirements

• Experience in pharmaceutical, biotechnology, or a related industry.
• Knowledge of quality assurance processes and FDA regulations.
• Ability to work on site regularly in Bend, OR.
• Strong attention to detail and clear written and verbal communication skills.
• Willingness to work night shifts (Sunday through Wednesday, 4:00 PM – 3:00 AM).

Culture & Benefits

• Medical, dental, and vision insurance.
• Relocation assistance available for eligible candidates and their families.
• Inclusive and ethical workplace with an agile career culture.
• Opportunities for career growth and professional development.
• Compensation programs that recognize high performance.