Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Specialist, Microbiology. The position will be based in Athens, GA.
At the 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.
The Quality Specialist, Microbiology will:
• Ensure product quality by developing and implementing strategies for managing microbial controls in manufacturing and laboratories.
• Execute protocols and reporting for environmental monitoring, high purity water system monitoring, and quality control testing.
• Designs, implements and maintains manufacturing environment and water system monitoring programs.
• Generates, peer reviews, queries, analyzes, trends, interprets, draws conclusions from, and reports quality control data.
• Conducts timely data trending reports for topics such as controlled manufacturing environment monitoring and high purity water system monitoring.
• Assesses microbial contamination controls, recommends and implements improvements with business partners to achieve business goals.
• Contributes to the resolution of complex non-conformance investigations for manufacturing and laboratory operations.
• Prepares for and participates in audits and inspections. Defends investigations and reports for internal and regulatory review.
• Performs and reviews microbiological analyses of raw materials, in-process and finished products, water testing and environmental monitoring. Performs biological indicator, growth promotion, endotoxin, and bioburden testing, and microbial identifications.
• Prepare media, standards, reagents, and glassware necessary for performing microbiological analyses, including appropriate controls and documentation.
• A minimum of an Associate’s Degree in Microbiology, Engineering, or a scientific related discipline with at least 8 years of experience in the field of microbiology, quality, or engineering is required; OR A minimum of a Bachelor's Degree in Microbiology, Engineering, or a scientific related discipline with at least 4 years of experience in the field of microbiology, quality, or engineering is required.
• An advanced degree (MS, MBA, PharmD, PhD, Etc) is preferred.
• Proficient with Microsoft Office software programs, including MS Outlook is required.
• Proven ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations is required.
• Must have proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical, chemical, and/or medical device manufacturing environment is required.
• Strong technical and troubleshooting skills are required.
• This position is located in Athens, GA and may require up to 25% local and domestic travel.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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Janssen Pharmaceuticals, Inc (6062)
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