Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist ensures that all quality systems, documentation, and processes comply with applicable GMP, FDA, and ISO regulations. This role focuses on reviewing batch records, inspecting and approving raw materials, managing deviations and change controls, and supporting continuous improvement through investigations and CAPAs. The specialist also performs shipping release procedures and provides comprehensive administrative support to the QA department, including document control, data compilation, and coordination of training activities.

Responsibilities

• Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements.
• Inspect and approve incoming raw materials to ensure they meet established quality specifications and documentation standards.
• Write and manage deviations, investigations, change controls, and CAPAs to address nonconformances and drive corrective and preventive actions.
• Perform shipping release procedures, ensuring that products meet all quality and documentation requirements prior to release.
• Support the preparation of Annual Product Review documentation for all marketed products, compiling data and ensuring timely completion.
• Provide administrative support to the QA department, including generating document change requests (DCRs), organizing files, and maintaining orderly records.
• Compile and analyze quality-related data to support reporting, trending, and continuous improvement initiatives.
• Coordinate QA-related training activities, including scheduling, tracking completion, and maintaining training records.
• Interact regularly with the electronic quality management system (EQMS) for document control, change management, and quality records.
• Collaborate with cross-functional teams, production areas, and other stakeholders to resolve quality issues and support compliance.
• Support internal and external audits by ensuring documentation is complete, organized, and readily accessible.
• Follow established quality procedures and contribute to the refinement of QA processes and documentation practices.

Essential Skills

• 2+ years of regulated industry experience in a GMP, FDA, or ISO environment for Specialist-level roles.
• 5+ years of regulated industry experience in a GMP, FDA, or ISO environment for Sr-level roles.
• Experience in quality assurance within a pharmaceutical or similarly regulated industry.
• Strong knowledge of GMP, FDA, and ISO quality system requirements and practices.
• Hands-on experience with batch record review and batch record documentation.
• Ability to write and manage CAPAs, deviations, investigations, and change controls.
• Experience with document control processes, including generating and processing document change requests (DCRs).
• Familiarity with audit processes and quality inspections in a regulated environment.
• Proficiency in using electronic quality management systems (EQMS) for document and quality record management.
• Strong attention to detail and accuracy in reviewing and maintaining quality documentation.
• Effective written and verbal communication skills for drafting quality documents and collaborating with cross-functional teams.
• Organizational skills for managing files, compiling data, and coordinating training activities.

Additional Skills & Qualifications

• Bachelor's degree in a science discipline preferred for Specialist and Sr roles.
• Experience in pharmaceutical manufacturing or related life sciences industries.
• Familiarity with Annual Product Review processes and requirements.
• Ability to work independently in an office-based QA environment while collaborating with production and other departments.
• Comfort with handling multiple priorities and deadlines in a regulated setting.
• Strong problem-solving mindset with a focus on continuous improvement of quality systems.

Work Environment

This is an on-site, office-based Quality Assurance role, located in an office area outside of production. The position operates Monday through Friday on first-shift hours, providing a stable weekday schedule. The specialist works primarily in an office or QA area, which may be shared or independent, with…