Quality Lab Associate II – Sterility Assurance

Location: Marion, North Carolina, United States

Salary: $80,000–$110,000 annually, with potential discretionary bonuses

Company

hirify.global develops healthcare products and services focused on saving and sustaining lives.

What you will do

• Author, revise, review, and maintain microbiology and sterility assurance documentation, including SOPs, work instructions, protocols, reports, forms, templates, and controlled records.
• Translate microbiology, contamination control, and laboratory practices into accurate, compliant, and executable documentation.
• Support change controls, CAPAs, investigations, continuous improvement initiatives, and process or facility changes.
• Identify documentation gaps, compliance risks, and process vulnerabilities, and recommend sustainable corrective actions.
• Prepare documentation packages and support audits, regulatory inspections, and document walkthroughs.
• Maintain version control, consistency standards, archival compliance, and documentation improvement practices.

Requirements

• Bachelor’s degree in Microbiology, Biology, Chemistry, Technical Writing, or a related scientific discipline.
• Five or more years of experience in a regulated pharmaceutical, medical device, or biologics environment.
• Experience with change management and document control systems.
• Working knowledge of GMP documentation principles, regulatory expectations, and quality system requirements.
• Understanding of microbiology, contamination control, and laboratory quality systems.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Previous experience writing or managing microbiology, sterility assurance, or manufacturing quality documentation.

Culture & Benefits

• Full-time employment with medical, dental, and vision coverage beginning on day one.
• 160 hours of paid time off, paid holidays, and paid parental leave.
• 401(k) matching and an employee stock purchase program.
• Tuition reimbursement and educational assistance.
• Work in a quality-focused environment guided by collaboration, accountability, and 6S principles.