Microbiology Analyst II Job at Johnson & Johnson
Janssen Ortho LLC, part of Johnson & Johnson Family of Companies, is recruiting for a Quality Control Analyst 2 (1 position) to be located in Gurabo, Puerto Rico.
Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- Conduct Laboratory tests in support of Solids production such as Microbial Purity Tests (finished product, raw materials, API) Water and Clean Steam Sampling and Testing, Bioburden and in process product tests, Biological Indicators (BIs) testing, Compress Air sampling, Media preparation, Growth promotion Test, Packaging components tests, Environmental Monitoring of manufacturing areas, isolates identification (IDs).
- Conduct Preservative Effectiveness Test.
- Support equipment qualification activities and new technology introduction.
- Support manufacturing area’s Start up activities.
- Provide technical knowledge to make decisions related to product quality from the microbiological standpoint during manufacturing processes as needed. Support Investigations and risk assessments when questionable microbiological results have been generated. Assure the compliance to all quality control policies, procedures, and systems to ensure the timely release of high-quality products of the supply chain process.
- Conduct routine and non-routine testing to support manufacturing operations (water environmental monitoring, equipment surface sampling.
- Support manufacturing processing investigations.
- Develop and present metrics to support manufacturing microbiological data evaluation and trending.
- Participate in external and internal cGMP audits.
- Support laboratory projects to assure compliance, costs reduction, laboratory operations efficiency and capacity's increase.
- Perform peer review of laboratory tests and environmental monitoring data.
- Support trending analysis, methods validations, methods transfers and special studies) protocols/reports.
Qualifications
- A minimum of a B.S. is required, a minor in Microbiology, Biology or Biotechnology is preferred.
- Proven experience in Quality Control is required.
- At least 3 (three) years of laboratory experience is required.
- Working experience in pharmaceutical operations is preferred.
- Experience in a Microbiology Laboratory GMP environment is required.
- Experience with MS Office (Word, Excel, PowerPoint) and in laboratory data entry systems (e.g. eLIMS) is preferred.
- Knowledge in method validations and transfers required.
- Familiarized with US and International GMPs and requirements for pharmaceuticals is required.
- Understanding of USP, EP, JP and FDA and International Regulatory Requirements.
- Fluent in Spanish & English (writing and speaking).
- Availability to work weekend’s shift.
- Flexibility to work on weekends and during irregular hours.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by crafting the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.]
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