QC Microbiologist Analyst

Johnson & Johnson Innovative Medicine•Gurabo, PR

9d•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 Johnson & Johnson is currently recruiting for a QC Microbiologist Analyst! This position will be located in Gurabo, Puerto Rico. Purpose: Reporting to the Quality Control leadership team, the QC Microbiologist Analyst is responsible for supporting microbiological testing activities within the Biosynthetic and Parenteral manufacturing operations. This role provides microbiological oversight and technical support to ensure compliance with GMP requirements, regulatory standards, and company quality systems. The analyst performs routine and non-routine microbiological testing, supports investigations, validations, environmental monitoring programs, and contributes to the timely release of high-quality products while maintaining compliance with all applicable procedures and regulations.

Requirements

A minimum of a Bachelor's degree (B.S.) is required.
Proven experience in Quality Control.
Experience in a Microbiology Laboratory GMP environment.
Background in aseptic processing.
Knowledge of method validations and method transfers.
Familiarity with U.S. and international GMPs and pharmaceutical regulations.
Fluency in Spanish and English (written and spoken).
Availability to work 3rd shift.
Flexibility to work on weekends and during irregular hours.

Nice To Haves

Degree concentration in Microbiology, Biology, Biotechnology, or a related Life Sciences discipline is preferred.
At least six (6) months of laboratory experience.
Experience supporting parenteral operations.
Experience with Microsoft Office (Word, Excel, PowerPoint) and laboratory data management systems such as eLIMS.
Understanding of USP, EP, JP, FDA, and other international regulatory requirements.

Responsibilities

Monitor activities of the Biosynthetic facility during third shift operations, included but not limited to: viable, surface and non-viable air sampling, water and compressed gases monitoring and testing.
Provide support to the microbiological aspects of the manufacture, validations and projects related to the parenteral area.
Conduct Laboratory tests in support of parenteral production such as Bacterial Endotoxin Tests (finished product, raw materials, WFI and Clean Steam), Bioburden and in process product tests, Sterility tests, Biological Indicators (BIs) testing, Environmental Monitoring of aseptic manufacturing areas, isolates identification (IDs).
Support equipment qualification activities and new technology introduction.
Provide technical knowledge to make decisions related to product quality from the microbiological standpoint during aseptic filling processes and media fills 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 parenteral operations (BET, environmental monitoring, Sterility testing.
Support aseptic 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.