Quality Specialist (Contingent Worker)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Octane Biotech (a Lonza company) is actively seeking a Quality Specialist (Contingent Worker) in Kingston, ON who will be responsible for participating in system implementation and improvement projects. Develops and maintains quality systems and practices which meet customer and regulatory requirements. Work autonomously to investigate, analyze and report post-market surveillance activities to management. Participate in customer/ regulatory body audits. Provide Quality System training activities. Support awareness, visibility, and communication on quality initiatives to support all areas of the organization.
- Participate in system implementation and improvement projects.
- Implement systems and procedures that assure compliance with quality standards based on the interpretation of Lonza’s standards and regulations.
- Provide training regarding Quality System processes.
- Maintain logs pertaining to Quality System processes as complaints, nonconformance reports, deviations, change control, CAPA, and training.
- Actively participate in third party customer/client and regulatory body audits (e.g., ISO audits etc.)
- Maintain quality records as per Octane Biotech /Lonza Quality System.
- Manage document control system.
- Support validation activities.
- Participate in the maintenance of design history files and device master records
- Advise service, R&D, and management team of complaint and post-market trending on regular basis.
- Participate in NCR/ CAPA/ Complaint/ Change Control review meetings,
- Act as back up to other Quality Specialist and Quality Control Technician.
- Product release of serviced instruments and approve Service Device History Files.
- Batch release of products.
- Conduct internal / supplier audits as required in support of Quality System requirements .
- Actively participate in continuous improvement activities, corrective action planning and customer satisfaction initiatives as assigned.
- Works with internal quality and other process owners to establish and maintain appropriate standards, guidelines and acceptance criteria.
- Ensures company compliance on Quality Policy, Quality Manual and Quality System Procedure requirements.
- Works closely with personnel from surrounding functional groups, including, but not limited to R&D, Manufacturing, Marketing, Servicing and Supply Chain as necessary to provide training and guidance in managing quality activities related to their functional areas.
- Demonstrates knowledge of, and supports, the Company’s mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality standards, and the code of ethical behavior.
- Informs QA Manager of all progress and issues.
- Responds to change productively and handles other essential duties as required or assigned.
- Sampling, inspection and measurement of incoming raw materials according to established material and component specifications
- Sampling, inspection and measurement of in‐process and finished devices according to applicable quality control specifications and procedures
- Ensure manufacturing compliance with detailed operating procedures
- Formal reporting of inspection and measurement results
- Ensure calibrations and preventative maintenance for all manufacturing equipment is up-to-date.
- University/College Degree in a Life Sciences or Engineering discipline
- American Society of Quality (ASQ) Certification (Auditing, Lean Six Sigma) preferred
- Working experience with a cGMP/Quality Management System in regulated industry.
- Strong computer skills and proficiency in written and verbal communication.
- Experience with database systems and MS Office applications.
- Thorough knowledge of GMP/GLP.
- Ability to problem solve and troubleshoot.
- Skill on manage their own daily tasks and project deliverables.
- Must be able to work in a team environment and have good interpersonal skills.
- Will be working on the shop floor as well as in the office.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.