PharMEDium Services, LLC is a growing outsource compounding organization servicing hospitals nationwide. Our growth now has encouraged our business to seek Senior Level QC chemists to perform and/or supervise analytical testing in our analytical testing lab. This position will report to the Quality Organization of PharMEDium.
Lead Analytical Chemist at this facility will perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. Lead Analytical Chemist will abide by all documentation procedures and maintain a level of professionalism throughout each working day. The chemist 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:
Schedule samples for analysis
Maintaining Specialized projects through efficient project management
Organize the receiving, storing and logging in of samples from the clean room or inventory
Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits
Create, review and approve data generated by other chemist
Maintenance of Laboratory Notebooks
Review and update standard operating procedures
Coordinate Instrument maintenance
Coordinate Method Transfers and Method Development
Write and execute protocols and reports
Lead OOS/Investigative reports
Develop Quality Reports
Train QC Chemist
Mentor and Supervise Chemist and Technicians
Actively participle in New Initiative involving Lab topics
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
B.S. in Chemistry with a minimum of 5 years of pharmaceutical analytical laboratory experience and 1 years of supervisory experience of own projects or staff members.
Experience in FDA regulated industry.
Strong knowledge of and troubleshooting of HPLC, UPLC, and UV vis
Effective organization and planning skills
Efficient in troubleshooting laboratory equipment
Amerisourcebergen Corporation - Corporate