Senior Quality Assurance Validation Specialist

Overview

• The Senior Quality Assurance Validation Specialist is a contract role focused on ensuring compliance with validation lifecycle requirements in a biopharmaceutical manufacturing environment.
• Collaborate with cross-functional teams to support validation activities, ensuring adherence to industry standards and regulatory guidelines.
• Provide expertise in analytical instrument qualification, data integrity assessments, and computer system validation processes.
• Contribute to the development and review of validation protocols, reports, and risk assessments.
• Support manufacturing operations through periodic reviews and audit trail evaluations.
• Ensure compliance with FDA and EMA regulations, maintaining high standards of quality and efficiency.
• Work onsite at the client’s manufacturing facility, providing hands-on quality assurance validation support.
• Utilize strong organizational and technical writing skills to document validation processes effectively.

Key Responsibilities & Duties

• Review and approve analytical instrument qualification protocols, reports, and specifications.
• Conduct periodic reviews and data integrity assessments for manufacturing operations.
• Evaluate equipment, facility, and utility system validation lifecycle documents, including risk assessments and qualification protocols.
• Represent Quality Assurance Validation in cross-functional project meetings, providing expert guidance.
• Collaborate with teams to ensure compliance with program SOPs, quality standards, and regulatory requirements.
• Provide weekly updates on project progress and hours utilized.
• Support continuous improvement initiatives within the validation processes.
• Maintain detailed documentation of validation activities and decisions.

Job Requirements

• Bachelor’s degree in Engineering, Microbiology, Chemistry, Biochemistry, or related scientific field.
• Minimum of 2 years of experience in GMP operations within biopharmaceutical or biotechnology industries.
• Proficiency in analytical instrument qualifications, computer system validation, and data integrity programs.
• Knowledge of FDA and EMA regulations and their application in validation processes.
• Strong technical writing and communication skills, with attention to detail and organizational abilities.
• Ability to manage multiple priorities and lead complex projects in a fast-paced environment.
• Experience with continuous improvement efforts in validation practices.
• Demonstrated analytical approach to problem-solving and decision-making.