PharMEDium Services, a division of AmerisourceBergen, is a growing outsourced compounding organization servicing hospitals nationwide. Our growth now has encouraged our business to seek a Senior Level QC supervisor to perform and/or supervise analytical testing in our analytical testing lab. This position will report to the Quality Organization of PharMEDium. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures. 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
- Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits. Must have the ability and experience to close audit responses and observations.
- Review and approve data generated by chemist
- Author and review protocols for development work
- Maintenance of Laboratory Notebooks
- Review and update standard operating procedures
- Active knowledge of current regulatory process and updates
- Coordinate Instrument maintenance
- Coordinate Method Transfers and Method Development
- Write and execute protocols and reports
- Understand 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 2 years of supervisory experience of multiple staff members.
- Experience of at least 2 years for managing lab and joint projects with outside departments
- Experience in FDA regulated industry.
- Actively participated in audits (internal and regulatory) with independent close out of observations
- Strong knowledge of and troubleshooting HPLC, UPLC, and UV vis
- Effective organization and planning skills
- Excellent technical and verbal skills
- Must have the ability to multi-task
- Have problem solving skill set
- Computer knowledge of data collection systems Empower and Win60 a positive and or spreadsheet software, Microsoft Word, Excel, and PowerPoint
- Understanding and experience utilizing the USP Compendia methods
- Knowledge of Aseptic Technique A PLUS!
- Advanced Knowledge and training of Chromatographic analysis, GMP documentation of experiments, and Quantitative Analysis.
- Ability to travel up to 10%
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