Senior Associate, Quality Assurance - Sterile Operations (Nights)

Location: West Chester, Ohio, USA; onsite sterile operations role. Monday–Friday, 5:00pm–1:30am.

Salary: $70,000–$115,000 per year.

Company

hirify.global is a technology-focused biomanufacturing company building high-tech, end-to-end manufacturing solutions for pharmaceutical production.

What you will do

• Perform QA review of batch records and associated manufacturing documentation.
• Execute and lead batch review, quality issue resolution, and documentation management processes.
• Collaborate with production and site support teams to maintain GMP compliance across projects and operations.
• Train and mentor Quality Associates and maintain the batch review tracker.
• Drive process improvements, conduct risk assessments, and benchmark QA practices.
• Monitor regulatory requirements and support quality metrics and KPI reporting.

Requirements

• Prior experience in the pharmaceutical industry or Quality Assurance.
• Knowledge of cGMPs and quality systems, with strong attention to detail and problem-solving skills.
• Ability to train and mentor peers and communicate effectively in writing and verbally.
• Ability to gown aseptically and successfully complete aseptic gowning qualification.
• Strong motivation and ability to learn.
• Work onsite in West Chester, Ohio, on the listed night shift.

Nice to have

• Bachelor’s degree; a Master’s degree in Quality or Regulatory Affairs is desirable.
• Experience in a Lean, process-centric organization focused on continuous improvement.
• Multi-site or multifunctional experience.
• Advanced Quality Assurance experience.

Culture & Benefits

• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, and vision coverage, plus life and disability insurance.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Tuition reimbursement and caregiving support.
• Visa and work authorization sponsorship are not available for this position.