Remote QA & Compliance Architect – Vaccines

WorkLLama; West Point (MS); Hybrid; USD 90,000 - 130,000; Full time

Job summary

WorkLLama in the United States is seeking a Quality Assurance Specialist – Large Molecule & Vaccines to ensure cGMP compliance across development and manufacturing. You will author and revise SOPs, organize training curricula, and ensure audit readiness.

You will work with SMEs across QA, Manufacturing, and Technical Operations to translate complex processes into clear procedures, and you will support deviations, CAPAs, and batch disposition as needed.

Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 5+ years of experience in biologics, vaccines, or large molecule QA/documentation.
• Experience authoring, reviewing, and revising SOPs and controlled documents.
• Strong knowledge of cGMP and global regulatory expectations.
• Experience with deviations, CAPAs, change controls, and batch disposition (preferred).

Responsibilities

• Author, review, and revise SOPs and controlled documents.
• Manage and maintain training curricula.
• Ensure inspection readiness and quality records.
• Collaborate with QA, Manufacturing, and Technical Operations SMEs.
• Support deviations, CAPAs, change controls, and batch disposition.

Skills

Technical writing

Attention to detail

Regulatory knowledge

Independent work

Education

Bachelor's degree in scientific/engineering field

Master's or Ph.D. preferred

Tools

SAP

QMS

LMS

AI content tools

Job description

WorkLLama in the United States is seeking a Quality Assurance Specialist – Large Molecule & Vaccines to ensure cGMP compliance across development and manufacturing. You will author and revise SOPs, organize training curricula, and ensure audit readiness.

You will work with SMEs across QA, Manufacturing, and Technical Operations to translate complex processes into clear procedures, and you will support deviations, CAPAs, and batch disposition as needed.