About Company
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by the diversity of our people and their experiences, and our commitment to living our Credo. We are committed to creating a healthy future for people and patients throughout the world by developing innovative solutions that address unmet medical needs. With a heritage spanning over 130 years, Johnson & Johnson is the world’s largest and most broadly based healthcare company, with diverse operations across consumer health, pharmaceuticals, and medical devices. We are driven by science and a deep commitment to improving human health, making a tangible difference in the lives of millions globally. Join our team and contribute to a company where the pursuit of excellence and a patient-first philosophy are at the core of everything we do.
Job Description
Are you a meticulous and dedicated Quality Assurance professional looking to make a significant impact in the healthcare industry? Johnson & Johnson, a global leader in health and wellness, is urgently seeking an experienced Quality Assurance Specialist to join our dynamic team in Guelph, Ontario. In this critical on-site role, you will be instrumental in upholding our unwavering commitment to product safety, efficacy, and regulatory compliance. You will work within a fast-paced environment, ensuring that all aspects of our product lifecycle, from development to manufacturing and distribution, adhere to the highest quality standards, both internal and external. This is an exceptional opportunity for a proactive individual who thrives on ensuring excellence and driving continuous improvement in a world-class organization.
As a Quality Assurance Specialist, you will play a pivotal role in maintaining the integrity and reliability of our products. You will be responsible for implementing and maintaining robust quality management systems (QMS), conducting thorough investigations into quality deviations, and actively contributing to a culture of quality across all operational functions. Your day-to-day will involve collaborating closely with manufacturing, R&D, and regulatory affairs teams to ensure that all processes and products meet stringent internal specifications and external regulatory requirements such as Health Canada, FDA, and ISO standards. We are looking for someone who is passionate about quality, possesses strong analytical skills, and has a proven track record in a regulated industry, particularly within pharmaceuticals or medical devices.
This role demands a keen eye for detail, excellent problem-solving abilities, and a collaborative spirit to work effectively with cross-functional teams. You will be expected to identify potential quality risks, propose preventative measures, and drive corrective and preventative actions (CAPA) to resolution. Furthermore, you will participate in internal and external audits, ensuring inspection readiness and successful outcomes. If you are ready to take on a challenging yet rewarding role where your expertise directly contributes to improving patient outcomes globally, we encourage you to apply today. This position offers not only the chance to work with cutting-edge technologies and processes but also significant opportunities for professional growth and development within the Johnson & Johnson family. Your dedication to quality will directly support our mission of helping people live healthier, more vibrant lives. Join us in Guelph and become a vital part of a team that is shaping the future of health.
Key Responsibilities
- Implement, maintain, and improve Quality Management Systems (QMS) in accordance with regulatory requirements (e.g., Health Canada, FDA, ISO).
- Conduct product and process quality inspections and audits to ensure compliance with established standards and specifications.
- Lead and participate in investigations into quality deviations, non-conformances, and customer complaints, driving root cause analysis and effective CAPA implementation.
- Review and approve quality-related documentation, including batch records, manufacturing procedures, and validation protocols.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality standards are integrated throughout the product lifecycle.
- Support internal and external audits (e.g., regulatory body inspections, supplier audits) and ensure inspection readiness.
- Provide training and mentorship on quality principles and practices to manufacturing and operational personnel.
- Monitor key quality performance indicators and contribute to continuous improvement initiatives.
- Ensure all activities adhere to Johnson & Johnson's Credo and all applicable environmental, health, and safety regulations.
Required Skills
- Bachelor's degree in Science, Engineering, or a related technical field.
- Minimum of 4 years of experience in Quality Assurance within a regulated manufacturing environment (Pharmaceutical, Medical Device, or Biotechnology).
- Strong understanding of cGMP, ISO 13485, Health Canada regulations, and/or FDA regulations.
- Proven experience with Quality Management Systems (QMS), CAPA, root cause analysis, and risk management.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong verbal and written communication skills with the ability to influence and collaborate effectively across all levels.
- Proficiency in Microsoft Office Suite.
Preferred Qualifications
- Master's degree in a relevant field.
- ASQ certifications (e.g., CQE, CQA).
- Experience with statistical process control (SPC) and Lean Six Sigma methodologies.
- Familiarity with electronic Quality Management Systems (eQMS).
- Previous experience in aseptic manufacturing or sterile product quality.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance coverage.
- Retirement savings plan with company match.
- Generous paid time off and holiday schedule.
- Opportunities for continuous learning and professional development.
- Access to employee wellness programs and resources.
- A collaborative and inclusive work environment committed to diversity.
- Employee stock purchase plan.
- On-site facilities (e.g., fitness center, cafeteria).
How to Apply
Interested candidates are encouraged to click on the application link below to submit their resume and cover letter. Please highlight your relevant experience in Quality Assurance within a regulated industry. We thank all applicants for their interest; however, only those selected for an interview will be contacted. Johnson & Johnson is an equal opportunity employer and values diversity.