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.
**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Gurabo, Puerto Rico, United States of America
Job Description:
**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 Analyst Quality Control, 3rd shift (2 positions) to be located in Gurabo, Puerto Rico.
Key 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.
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 two (2) years of laboratory experience is required.
- Working experience in aseptic operations is preferred.
- Experience in a Microbiology Laboratory GMP environment is required.
- Background in aseptic processing 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 3rd shift
- Flexibility to work on weekends and during irregular hours.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy