About Company
Join Hiring.zycto, a dynamic pharmaceutical innovator where precision meets progress. We are dedicated to advancing healthcare through rigorous scientific research and the development of high-quality, life-changing medications. For a Quality Assurance Associate, this means working at the forefront of regulatory excellence, ensuring every product meets the highest standards of safety and efficacy. We champion a culture of meticulous attention to detail and continuous improvement, providing an environment where your commitment to quality directly impacts patient well-being. Here, your expertise is valued, and your contributions are essential to our collective success in the pharmaceutical landscape.
Job Description
Are you a meticulous professional with a passion for pharmaceutical quality and regulatory compliance? Hiring.zycto is seeking a dedicated Quality Assurance Associate to join our growing team in Greektown, Toronto. In this critical role, you will be instrumental in upholding the stringent quality standards that define our products and processes, directly contributing to our reputation for excellence and patient safety.
As a Quality Assurance Associate, you will contribute significantly to maintaining our robust Quality Management System (QMS). Your day-to-day will involve a diverse range of activities, from reviewing and approving batch records, ensuring strict adherence to Good Manufacturing Practices (GMP), to actively participating in internal and external audits. You will be a key player in investigations of deviations, out-of-specification (OOS) results, and customer complaints, meticulously documenting findings and collaborating with cross-functional teams, including R&D, Production, and Regulatory Affairs, to implement effective corrective and preventive actions (CAPAs). This role requires a proactive approach to identifying potential quality issues and developing sustainable solutions.
This position demands a keen eye for detail, a strong understanding of current pharmaceutical regulations (including Health Canada, FDA, and ICH guidelines), and the ability to work collaboratively in a fast-paced, highly regulated environment. You will be responsible for ensuring that all manufacturing, packaging, and testing operations comply with established procedures and regulatory requirements, thereby safeguarding product integrity and patient safety at every stage of the product lifecycle. Your expertise will be vital in ensuring that all documentation is accurate, complete, and readily retrievable for inspection.
Your impact at Hiring.zycto will extend beyond routine checks; you will actively contribute to process improvements, participate in risk assessments, and help drive a proactive quality culture throughout the organization. We are looking for an individual who is not only proficient in QA principles but also eager to learn, adapt, and grow within the dynamic pharmaceutical industry. If you are committed to excellence, possess a strong ethical compass, and are ready to make a tangible difference in the lives of patients by ensuring the highest standards of pharmaceutical quality, we encourage you to apply and become a part of our mission to deliver superior and safe pharmaceutical solutions.
Key Responsibilities
- Review and approve batch production records, deviations, OOS results, and change controls.
- Ensure strict compliance with GMP, Health Canada, FDA, and ICH guidelines.
- Participate in internal and external audits, including vendor qualification and management.
- Investigate and document quality events, deviations, and customer complaints, including root cause analysis.
- Collaborate with cross-functional teams on CAPA implementation and effectiveness checks.
- Assist in the development, revision, and control of QMS documentation (SOPs, policies, work instructions).
- Provide quality oversight for manufacturing, packaging, and laboratory operations.
- Conduct product release activities for intermediate and finished goods.
- Contribute to risk assessments, continuous improvement initiatives, and quality metrics reporting.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Pharmacy, Biology).
- Strong understanding of GMP, ICH guidelines, and pharmaceutical regulations (Health Canada, FDA).
- Excellent written and verbal communication skills for documentation and collaboration.
- Proficiency in root cause analysis and CAPA methodology.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and as part of a collaborative team.
- Familiarity with quality management systems (QMS) software.
- Experience in pharmaceutical manufacturing or quality control environment.
Preferred Qualifications
- Master's degree in a related field.
- Experience with sterile manufacturing or aseptic processing environments.
- Certification in quality assurance (e.g., ASQ Certified Quality Auditor, CQA).
- Familiarity with environmental monitoring programs and data interpretation.
- Project management experience within a QA or regulatory context.
Perks & Benefits
- Comprehensive health, dental, and vision insurance coverage.
- Generous paid time off and public holidays.
- Opportunities for professional development and continuing education.
- Matched RRSP contribution program.
- Employee wellness initiatives and programs.
- Dynamic, collaborative, and inclusive work environment.
- On-site parking or public transit subsidy.
How to Apply
Ready to make a difference? Please click the application link below to submit your resume and cover letter. We look forward to reviewing your qualifications and learning more about your passion for quality assurance in pharmaceuticals.
