Job Description:
We are seeking a highly skilled and motivated QA Manufacturing Compliance Specialist (Biologics) to join our team. The ideal candidate will have a strong background in quality assurance, compliance, and biologics manufacturing processes. As a QA Manufacturing Compliance Specialist, you will play a critical role in ensuring that our manufacturing operations comply with regulatory standards and internal quality requirements. You will work closely with cross-functional teams to maintain the highest standards of quality and compliance in our biologics manufacturing processes.

Key Responsibilities:

• Develop, implement, and maintain quality assurance programs and procedures to ensure compliance with regulatory standards (e.g., FDA, EMA) and internal policies.
• Conduct regular audits and inspections of manufacturing processes to ensure compliance with GMP, GLP, and other relevant quality standards.
• Monitor and report on the status of manufacturing compliance activities to senior management.
• Investigate and resolve quality issues related to manufacturing processes, equipment, and materials.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure compliance with quality standards.
• Prepare and review documentation required for regulatory submissions and inspections.
• Provide training and guidance to manufacturing personnel on quality assurance and compliance requirements.
• Implement corrective and preventive actions (CAPAs) to address quality issues and improve manufacturing processes.
• Stay current with industry trends, regulatory changes, and best practices related to biologics manufacturing and quality assurance.
• Participate in regulatory inspections and audits related to manufacturing compliance activities.

Qualifications:

• Bachelor’s degree in Biological Sciences, Biochemistry, Biotechnology, or a related field. Advanced degree preferred.
• Proven experience in a quality assurance role within the biopharmaceutical or biologics industry.
• Strong knowledge of regulatory requirements and guidelines for biologics (e.g., FDA, EMA, ICH).
• Experience with GMP, GLP, and other relevant quality standards in a biologics manufacturing environment.
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.
• Proficiency in using quality management and compliance software tools.
• Ability to work effectively in a cross-functional team environment.
• Knowledge of lean manufacturing principles is a plus.

Benefits:

• Competitive salary and comprehensive benefits package.
• Opportunities for career advancement and professional development.
• Collaborative and innovative work environment.
• Access to the latest technologies and tools in biologics manufacturing.
• Contribution to groundbreaking biologic therapies that improve patient lives.