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Mississauga, Ontario, Canada Resilience Full timeAbout the Position:Resilience is seeking a highly skilled and experienced Senior Specialist II to join our Quality Assurance team. As a key member of our team, you will play a critical role in championing sterility assurance principles at our site and serving as the technical leader in microbiological control.Key Responsibilities:Maintain and implement site...
Senior Specialist II, QA Operations Expert
1 month ago
At Resilience, we're revolutionizing the biomanufacturing industry with cutting-edge technology and sustainable solutions. As a Senior Specialist II, QA Operations, you'll play a crucial role in ensuring the highest standards of quality and compliance in our sterile manufacturing environment.
Key Responsibilities:- Develop and implement sterility assurance strategies to maintain site compliance with regulatory requirements.
- Lead microbial and cross-contamination risk assessments, ensuring alignment with global microbiological standards.
- Collaborate with cross-functional teams to resolve quality and compliance issues, providing expert guidance on sterility assurance and GMP compliance.
- Participate in new product introductions, ensuring new products and processes meet rigorous microbial and viral control standards.
- Conduct audits and checks to ensure all work is performed in compliance with GMP, SOPs, and regulatory requirements.
- Extensive experience in sterile manufacturing environments.
- Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, and clean room qualification.
- Demonstrated expertise in cGMP/ICH/FDA/EU/Health Canada compliance regulations.
- Excellent problem-solving, risk management, and communication skills.
- A competitive salary range of $90,000 to $131,250 per year.
- A comprehensive benefits package, including equity, annual cash bonus, RRSP/DPSP, and more.
- A dynamic and supportive work environment with opportunities for growth and development.
Resilience is an equal opportunities employer committed to diversity and inclusion. We welcome applications from qualified candidates who share our passion for innovation and excellence.
