Quality Specialist - II (Associate)

We are currently seeking a Quality Specialist for a prominent client of ours. This position is based out of West Point, PA, and can be remote or hybrid, paying $40-45.86/hr for a contract opportunity.

Important: This role specifically requires experience supporting biologics/large molecule operations. Candidates with a background in general QA documentation but without biologics, vaccine, or large molecule experience may not be a fit.

Job Details:

• Position: Quality Specialist
• Duration: 1 year assignment with possibility of extension or conversion.
• Location: West Point, PA
• Pay: $40-45.86/hr
• Work Arrangement: Remote or Hybrid
• Schedule: Monday-Friday, EST hours
  
  

About the Role:

This role will support biologics and large molecule development and manufacturing operations through GMP documentation, quality systems, SOP development, training materials, and inspection readiness. The ideal candidate will have hands-on experience in biologics/large molecule operations, along with a strong understanding of GMP requirements and the ability to translate complex technical information into clear, compliant documentation.

Key Responsibilities:

• Support large molecule/biologics development and manufacturing activities in alignment with GMPs and global regulatory expectations
• Author, review, and revise SOPs, work instructions, controlled documents, and training materials
• Organize and maintain training curricula to ensure role-based requirements remain current and complete
• Review documentation and identify compliance risks, documentation gaps, and opportunities for improvement
• Support inspection readiness by maintaining accurate, organized, and readily retrievable documentation
• Provide cross-functional quality support to Manufacturing, Technical Operations, QA, and other stakeholders
• Work with SMEs to translate complex technical information into clear procedures and training content
• Support quality systems and documentation activities related to deviations, CAPAs, change controls, batch disposition, and other GMP processes
  
  

Qualifications:

• Bachelor’s degree is Required!
• 3-5 years of experience in biologics/large molecule operations
• Experience in QA, Manufacturing, Technical Operations, or GMP documentation within biologics, vaccines, or large molecule operations
• Strong working knowledge of GMP/GDP regulations
• Experience authoring, reviewing, or revising SOPs, controlled documents, work instructions, or training materials
• Experience with clinical supply is preferred.
• Familiarity with deviations, CAPAs, change controls, batch disposition, and inspection readiness
• Strong technical writing, organizational, analytical, and problem-solving skills
• Proficiency with SAP or other ERP systems is a plus
  
  

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