PharMEDium Services, LLC, an AmerisourceBergen Company, 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.
The EPA 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.
- 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
- 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