Quality Specialist - II (Associate)

Location: West Point, Pennsylvania; hybrid or remote work arrangements available, Monday–Friday aligned with Eastern Time

Salary: $88,800 annually

Company

Staffing and workforce solutions provider offering temporary assignments and contractor placements.

What you will do

• Support biologics and vaccine development and manufacturing activities in accordance with GMP requirements and global regulatory expectations.
• Author, review, and revise SOPs, work instructions, controlled documents, and training materials.
• Maintain role-based training curricula and keep requirements current and complete.
• Identify compliance risks, documentation gaps, and improvement opportunities.
• Support inspection readiness by ensuring documentation is organized, accurate, current, and retrievable.

Requirements

• Bachelor’s degree in science, engineering, or a related discipline; an advanced degree is preferred.
• At least five years of experience in biologics or large molecule operations.
• Experience in quality assurance, manufacturing, technical operations, or GMP documentation within biologics, vaccines, or large molecule operations.
• Working knowledge of GMP requirements and global regulatory expectations.
• Experience authoring, reviewing, or revising SOPs, controlled documents, or training materials.
• Strong technical writing, analytical, organizational, collaboration, and attention-to-detail skills.

Nice to have

• Experience with biologics, vaccines, sterile manufacturing, clinical supply, deviations, CAPAs, change controls, batch disposition, or inspection readiness.
• Experience with document management, learning management, or quality management systems.
• Proficiency with Microsoft PowerPoint, Excel, Word, the Microsoft Office Suite, and preferably SAP.
• Ability to use AI-enabled tools to support training content development.

Culture & Benefits

• Work independently while collaborating across a matrixed environment and with subject matter experts.
• 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.