Quality Control Specialist

We are seeking an experienced Documentation (QC) Specialist to support quality documentation, specifications, methods, and change control activities within a pharmaceutical manufacturing environment. This role will be responsible for reviewing and maintaining commercial testing methods, specifications, and global testing standards while ensuring compliance with cGMP and regulatory requirements.

• Review, manage, and maintain commercial specifications, analytical methods, and supporting QC documentation
• Perform content review and quality approval of change controls, testing standards, and method documents
• Support creation, revision, and lifecycle management of specifications and testing methods
• Maintain document management systems and ensure accurate document control practices
• Manage Global Testing Standards (GTS) documents, notifications, and document obsolescence activities
• Support change management initiatives and ensure compliance with quality and regulatory requirements
• Collaborate with QA, QC, Regulatory, Manufacturing, Stability, Supply Chain, and R&D teams

• 4+ years of Pharmaceutical, Biotech, or related industry experience
• Strong knowledge of QC methods, specifications, compendial requirements, and cGMP regulations
• Experience with document management systems, change controls, and quality documentation
• Familiarity with SAP, LIMS, or related laboratory systems preferred
• Strong attention to detail, communication, project management, and cross-functional collaboration skills