Manufacturing Quality Specialist (Oligonucleotide Manufacturing)

Location: Louisville, KY, USA; Tuesday to Saturday, 3 PM to 12 AM. The role involves working in office and manufacturing environments.

Company

hirify.global is an international life sciences company providing analytical testing, laboratory, genomics, pharmaceutical, environmental, food, and clinical diagnostic services.

What you will do

• Support investigations of customer complaints and product returns, including documentation and resolution of quality concerns.
• Perform final quality control checks and provide backup support to QC technicians.
• Audit manufacturing processes for risk mitigation, regulatory compliance, and continuous improvement.
• Manage nonconformances, lead root cause investigations, and oversee CAPA implementation and effectiveness checks.
• Collaborate with production and engineering teams on process optimization, equipment validation, and quality improvements.
• Monitor manufacturing KPIs, support QMS activities, maintain documentation practices, and train production staff on quality standards.

Requirements

• Bachelor’s degree in engineering, life sciences, chemistry, or a related field.
• At least 3 years of experience in quality assurance or manufacturing quality control within a regulated industry.
• Working knowledge of 21 CFR 820, ISO 9001, and ISO 13485.
• Experience with quality audits, nonconformance management, root cause analysis, and CAPA initiatives.
• Strong problem-solving, communication, organizational, and time-management skills.
• Ability to work collaboratively in a fast-paced production environment.

Nice to have

• Master’s degree in a relevant field.
• Experience in pharmaceutical, medical device, or food manufacturing.
• Proficiency with quality management software, risk management tools, manufacturing processes, and equipment.

Culture & Benefits

• Full-time employment with comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) plan with company match.
• Paid vacation and holidays.
• Work across office and manufacturing settings with cross-functional production, engineering, and quality teams.