Manager, Quality Assurance - Licaps
United States, Greenwood (South Carolina)
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.
The Quality Assurance Manager is responsible to direct and coordinate the quality system efforts within the Greenwood DFS plant ensuring compliance to Dietary Supplement standards. Consistently recognize opportunities for improvement in the overall quality based on external and internal quality indicators. Communicate directly with management in regards to quality, validation, document control, in-process sampling and batch record requirements. Must be able to exercise judgment, meet deadlines, and be a strong team leader. This position is responsible for strengthening product safety and quality systems throughout the plant. They will prepare and lead all audit functions and provide recommendations for corrective and preventive actions. Partnering with Manufacturing to ensure product compliance is an essential element of the position.
- Promote and establish a safe work environment for Quality colleagues.
- Provide leadership for continued growth of internal quality systems and customer experience.
- Lead and oversee development, implementation, and maintenance of the current audits and certifications (FDA, NSF, TGA cGMP, Organic, etc.)
- Establish and maintain compliance to Quality Management system in accordance to corporate and global regulatory requirements.
- Design and improve quality systems for multiple departments ranging from raw material, operations, customer service to product distribution.
- Develop and approve Standard Operating Procedures (SOP’s) in packaging and quality departments
- Perform root cause analysis for customer complaints and production deviations. Initiate and achieve non-conformance event investigations.
- Works cooperatively with Manufacturing, Product Development, and Quality Control Labs.
- Responsible for the management and oversight of contracted facility product safety prerequisites, e.g. pest control, water management, lubricant and chemical safety, etc.
- Monitor the performance and competency of Quality Assurance staff and provide development as needed
- Direct validation objectives within the Greenwood DFS plant. Keep activities in line with FDA, NSF, TGA and Lonza requirements. Lead validation efforts on Greenwood projects, processes and systems. Ensure full compliance and execution of Validation Master Plan.
- Support continuous improvement strategy by leading quality improvement teams though six sigma methodology.
- Leader and responsible for all batch record approvals and in-process sampling/auditing.
- Ensure accuracy and compliance for all quality systems to include Deviations, Risk Assessments, Data Integrity, CAPA and change control.
- Lead and ensure compliance to all GMP, Social and Lifestyle certifications.
- Bachelors of Engineering, Analytical Industrial Management or Business Administration
- Knowledgeable with decimal and measurement conversions, math skills, and statistical process controls.
- Prior manufacturing quality assurance management experience within the nutritional dietary supplement manufacturing industry is required.
- Supervisory / management experience required.
- Proficient in Microsoft Word, Excel, Outlook
- Flexible scheduling of hours, including weekends as needed
- Excellent written and verbal communication skills
- Self-motivated and able to work with limited supervision
- Moderate travel required, domestic and international
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.