Quality Specialist - II; Associate

Position: Quality Specialist - II (Associate) (26-12646)
Notes:
Open to Hybrid or remote. EST shifts(Monday-Friday) BVDQ Contractor

Job Description – Large Molecule QA The Large Molecule QA Contractor will support biologics and vaccine development operations by applying GMP knowledge, global regulatory expectations, and quality systems experience. Responsibilities include SOP authorship/revision, training curriculum organization, documentation review, and cross-functional quality support.

Key Responsibilities Support large molecule development and manufacturing activities in alignment with GMPs, quality standards, and global regulatory expectations. Author, review, and revise SOPs, work instructions, and controlled documents. Maintain training curricula to ensure role-based requirements are current and complete. Identify compliance risks, documentation gaps, and improvement opportunities. Support inspection readiness through organized, accurate, and retrievable documentation.

Required Qualifications Bachelor’s degree in science, engineering, or related discipline; advanced degree preferred. Minimum 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. Working knowledge of GMPs and global regulatory expectations. Experience authoring, reviewing, or revising SOPs, controlled documents, or training materials. Strong attention to detail, technical writing, and organizational skills.

Ability to work independently and collaborate in a matrixed environment. Preferred Skills and Experience

Experience with biologics, vaccines, sterile manufacturing, or clinical supply. Familiarity with deviations, CAPAs, change controls, batch disposition, and inspection readiness.

Experience with document, learning, or quality management systems. Ability to translate requirements into clear, compliant documentation. Ability to manage multiple priorities in a dynamic environment. Key Competencies Quality and compliance mindset Technical writing Collaboration Risk-based problem solving Attention to detail Adaptability in a GMP environment Software Skills Microsoft PowerPoint (strong proficiency preferred) Microsoft Excel Microsoft Word Microsoft Office Suite SAP (preferred) Ability to appropriately leverage AI tools for training content development Industry Experience Preferred Pharmaceutical industry Biotechnology industry Large Molecule/Biologics manufacturing and development Clinical Supply environment (nice-to-have) Quality oversight within manufacturing or development operations Soft Skills Strong analytical and critical-thinking skills Excellent written communication Attention to detail Ability to organize large volumes of documentation Stakeholder collaboration Ability to work with SMEs and translate complex information into clear procedures and training materials Self-starter with strong time-management skills.