Experienced Analyst Quality Assurance

Johnson & Johnson • Cornelia, GA

1d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech. An pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for Experienced Analyst Quality Assurance position. This role will report directly to the Laboratory Supervisor and will perform routine and complex instrument qualification in compliance with laboratory procedures to support the lab and manufacturing and timely delivery of product to customers. This role will receive general instructions about required tasks and results expected. Work will be well defined and will be reviewed for accuracy upon completion. The role is expected to apply standard practices and techniques in specific situations and to recognize discrepancies in results and follow operations through a series of detailed steps and processes. Additionally, the role has accountability and ownership to maintain laboratory instruments in their qualified state in accordance with Instrument Lifecycle Process Management. You will be responsible for: Develop and revise laboratory Lifecycle Management SOPs. Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence. Support validation protocols execution. Provide hands-on and effective diagnostics/troubleshooting functions Support the design and implementation of sound Technical solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with standards and cGMP regulatory requirements. Provide laboratory support for capital projects concurrently with a dynamic workload based upon site priorities Applies functional knowledge of Quality Control standards to review results of quality audits and regulatory inspections, identify quality issues, and provides support corrective action plans.

Requirements

• University/bachelor’s degree in Science / Technical discipline.
• 2-4 years of related work experience.
• Strong background and knowledge of Laboratory cGMP Environment.

Nice To Haves

• Experience in medical devices or life science management, quality management or related field (Medical Devices, Pharma, biotechnology, or equivalent).

Responsibilities

• Develop and revise laboratory Lifecycle Management SOPs.
• Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
• Support validation protocols execution.
• Provide hands-on and effective diagnostics/troubleshooting functions.
• Support the design and implementation of sound Technical solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with standards and cGMP regulatory requirements.
• Provide laboratory support for capital projects concurrently with a dynamic workload based upon site priorities.
• Applies functional knowledge of Quality Control standards to review results of quality audits and regulatory inspections, identify quality issues, and provides support corrective action plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level