The Quality Assurance Specialist - Large Molecule & Vaccines will support biologics and vaccine development operations by applying robust cGMP knowledge, quality systems expertise, and global regulatory compliance standards. In this dynamic role, you will be responsible for authoring and revising controlled technical documentation, organizing training curricula, conducting documentation reviews, and partnering cross-functionally across development and manufacturing teams. Working closely with Subject Matter Experts (SMEs), you will help translate complex operational processes into clear, compliant procedures while ensuring continuous audit and inspection readiness.
Responsibilities- Support large molecule and vaccine development and manufacturing activities in full alignment with cGMP guidelines, internal quality standards, and global regulatory expectations.
- Author, review, and revise Standard Operating Procedures (SOPs), work instructions, and controlled technical documents.
- Manage and maintain role-based training curricula to ensure compliance requirements are accurate, complete, and current.
- Identify compliance risks, documentation gaps, and process improvement opportunities across quality and operational workflows.
- Ensure inspection readiness by maintaining organized, accurate, and easily retrievable quality records and documentation.
- Collaborate cross-functionally with QA, Manufacturing, and Technical Operations SMEs to translate complex operational requirements into actionable, standardized procedures.
- Utilize software tools, Quality Management Systems (QMS), Learning Management Systems (LMS), and appropriate AI tools to draft, organize, and streamline training content and quality documentation.
- Support additional quality management tasks such as deviations, CAPAs, change controls, and batch disposition activities as needed.
Education- Minimum Required: Bachelor's degree in a scientific, engineering, or related discipline.
- Preferred: Advanced degree (Master's or Ph.D.) in a related field.
Experience- Minimum of 5 years of experience in biologics, vaccines, or large molecule operations within QA, Manufacturing, Technical Operations, or GMP documentation.
- Proven experience authoring, reviewing, and revising SOPs, controlled documents, or technical training materials in a regulated GMP environment.
- Deep working knowledge of cGMP principles and global regulatory expectations (FDA, EMA, etc.).
- Preferred experience with quality management processes including deviations, CAPAs, change controls, batch disposition, and inspection readiness.
- Preferred experience navigating QMS, LMS, SAP, or electronic document management platforms.
- Preferred background supporting sterile manufacturing or clinical supply operations within the pharmaceutical or biotechnology industries.
Additional Information- Work Location & Hours: Open to Hybrid or Remote work arrangements operating on Standard Eastern Time (EST) hours (Monday - Friday).
- Technical & Software Skills: Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), with preferred experience using SAP and AI content development tools.
- Key Competencies: Exceptional technical writing capabilities, strong risk-based problem solving, meticulous attention to detail, and proven ability to work independently in a matrixed organization.
