Quality Specialist (Biologics)

Location: Rahway, New Jersey 07065, United States; hybrid or remote work available; EST shifts, Monday–Friday

Salary: $89,200–$95,400 annually

Company

hirify.global provides staffing and employment opportunities for technical and scientific professionals.

What you will do

• Support quality activities within biologics, vaccines, large-molecule, manufacturing, or clinical supply operations.
• Author, review, and revise SOPs, controlled documents, and training materials.
• Translate GMP and global regulatory requirements into clear, compliant documentation.
• Contribute to deviations, CAPAs, change controls, batch disposition, and inspection readiness activities.
• Collaborate with subject-matter experts and stakeholders in a matrixed environment.

Requirements

• Bachelor’s degree in science, engineering, or a related discipline; an advanced degree is preferred.
• At least 5 years of experience in biologics or large-molecule operations.
• Experience in QA, manufacturing, technical operations, or GMP documentation within biologics, vaccines, or large-molecule operations.
• Working knowledge of GMPs and global regulatory expectations.
• Strong technical writing, analytical, organizational, and collaboration skills.
• Proficiency with Microsoft Excel, Word, and Office Suite; PowerPoint proficiency preferred.

Nice to have

• Experience with biologics, vaccines, sterile manufacturing, or clinical supply.
• Experience with document, learning, or quality management systems.
• Experience with SAP.
• Ability to use AI tools for training content development.

Culture & Benefits

• Hybrid or remote work arrangement with EST schedule alignment.
• Independent work and collaboration in a matrixed environment.
• Temporary assignments lasting 13 weeks or longer may include medical, dental, vision, 401(k), and statutory sick pay where required.
• Reasonable accommodations are available during the employment process.