PharMEDium Services, LLC is a growing outsource compounding organization servicing hospitals nationwide. Our growth now has encouraged our business to seek Scientist to perform and analytical testing in our testing lab. This position will report to the Quality Organization of PharMEDium.
Scientist at this facility will perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. Scientist will abide by all documentation procedures and maintain a level of professionalism throughout each working day. The scientist must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures. All applicants for this position must embody and demonstrate the PharMEDium Core Values: Patient Safety, Flawless Quality, Operational Excellence, Employee Well Being, Service Excellence, and Respectful and Collaborative Environment.
PRIMARY DUTIES AND RESPONSIBILITIES:
Perform testing using aseptic technique in a laminar Airflow clean bench
Per procedures maintain all documents for laboratory analysis
Perform rapid sterility testing per procedure and report result per cGMP/GLP Guildlines
Receiving, Storing and logging in samples for testing analysis
Identify OOL results and follow the guidance of supervision through investigation process
Generating Quality Data Trend Reports
Peer Review of Data via other scientist and sterility technicians
Keeping the laboratory clean
Ordering supplies and other materials
Follow Standard Operating Procedures
Reviews and Updates Standard Operating Procedures
Maintenance of Laboratory Notebooks
Support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
B.S. Degree in Applicable Science field with minimum of 3 years of preferred pharmaceutical laboratory experience
Aseptic Technique knowledge preferred
Preferred experience with FDA regulated industry
Strong knowledge of sterility lab equipment and supporting laboratory equipment.
Efficient in troubleshooting laboratory equipment.
Effective organization and planning skills
Excellent technical and verbal skills
Computer knowledge of data collection and/or spreadsheet software, Microsoft Word and Excel
Knowledge of Chromatographic analysis, GLP documentation of experiments, and Qualitative testing
Amerisourcebergen Corporation - Corporate