QC Microbiologist Analyst

Johnson & Johnson•Gurabo, PR

2d•Onsite

About The Position

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for QC Microbiologist Analyst. You will be responsible for: 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 biosynthetic operation. Conduct Laboratory tests in support of biosynthetic operation such as Bacterial Endotoxin Tests (IPC, 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 biosynthetic 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.

Requirements

A minimum of a B.S. is required
Proven experience in Quality Control is required.
At least two (2) years of laboratory experience is required.
Experience in a Microbiology Laboratory GMP environment is required.
Background in aseptic processing required.
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 3rd shift is required.
Flexibility to work on weekends and during irregular hours is required.

Nice To Haves

a minor in Microbiology, Biology or Biotechnology is preferred.
Working experience in aseptic operations is preferred.
Experience with MS Office (Word, Excel, PowerPoint) and in laboratory data entry systems (e.g. eLIMS) is preferred.

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 biosynthetic operation.
Conduct Laboratory tests in support of biosynthetic operation such as Bacterial Endotoxin Tests (IPC, 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 biosynthetic 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.