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Sterilization QA Specialist
1 month ago
Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a Sterilization QA Specialist located in its manufacturing site at San Lorenzo, Puerto Rico.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
The Sterilization QA Specialist reports to Quality Laboratory Leader or designee and working directly with the Sterilization Site Lead; and with the objective of maintaining high quality standards for the product manufacturing process and in compliance with regulatory requirements, performs data analysis to support process improvements and decision making and performs other functions to support the Quality Assurance Department at Ethicon LLC. Supports the Dry Heat, EO and Gamma sterilization execution maintenance activities.
Engage in the Quality Assurance operation in accordance with the QSR, ISO and Ethicon written specifications and quality standards. Support cost improvement projects at plant level and prepare reports (using the computer system) as assigned.
Responsibilities:
- Support the Dry Heat, EO and Gamma sterilization execution maintenance activities.
- Oversee the daily sterilization operations, including review of deviations and corrections, and trend assessments. Provide technical support to sterilization process.
- Execute periodic qualifications and performance metrics for sterilization process.
- Assess impact of product/process change control for sterilization.
- Conduct EO, Gamma, and Dry heat cycle re-qualifications.
- Monitor bioburden program.
- Provide support for any non-conformance, product disposition and CAPA.
- Data Analysis, Process Improvements and Decision Making:
o Exercise initiative, leadership and decision making to solve quality-related issues with other departments' organization members and other Ethicon sites' organization members.
o Perform data analysis and recommend disposition of material.
o Participate in non-conformances' investigations and root cause analysis.
o Submit changes and support implementation of changes in the documentation system.
Qualifications
- A minimum of a bachelor's degree in science, Engineering, Bio Medical or related field is required.
- A minimum of two (2) years of experience in the regulated manufacturing industry is required.
- Understanding of environmental control, packaging, and manufacturing process impact on sterility assurance is required.
- Knowledge in ISO, FDA and other regulated standards is required.
- Bilingual (Spanish & English), written and oral is required.
- Advanced computer skills (Microsoft Office) and use of software application(s) are required. Experience with LIMS or JDE is preferred.
- Working knowledge on Quality Systems, such as CAPA and non-conformance systems is required.
- Availability to work a 1st, 2nd, and 3rd shift is required. Must be able to work extra hours, at night or on weekends and irregular shifts.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.
