Senior Quality Associate

Senior Quality Associate – Biotechnology As a Biotechnology QA Sr. Associate, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. Key Responsibilities:

 

• Develop and maintain quality assurance procedures, policies, and systems.
• Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
• Collaborate with production and QC teams to ensure product quality throughout the manufacturing process.
• Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
• Stay current with industry regulations, guidelines, and best practices.
• Assist in the preparation and execution of regulatory inspections and audits.
• Ensure that all products meet regulatory requirements, including documentation and reporting.
• Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports.
• Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.
• Perform batch disposition, including approval of drug substance batch records and associated CoA’s.
• Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
• Participate in risk assessments and quality improvement projects.
• Provide training to staff on quality-related procedures and best practices.
• Stay informed about the latest developments in biotechnology and quality assurance.

• Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
• Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
• Excellent problem-solving and analytical skills.
• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Effective communication and teamwork skills.
• Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
• Experience with quality management systems (e.g., TrackWise, MES) is a plus.