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.
Schedule samples for analysis
Support specialized projects
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 draft submission ready responses to audit observations.
Review and approve data generated by biologists
Maintenance of Laboratory Notebooks
Review and initiate the revision of standard operating procedures
Active knowledge of current regulatory process and updates in the area of responsibility
Coordinate Instrument maintenance with Laboratory Metrology
Coordinate Method Transfers and Method Development
Write and execute protocols and reports
Understand OOS/Investigative reports
Develop Quality Reports
Mentor and Supervise Biologists and Technicians
Actively participle in New Initiative involving Lab topics
B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 0-2 years of supervisory experience of multiple staff members.
Must have environmental monitoring experience
Experience in FDA regulated industry.
Actively participated in audits (internal and regulatory) with independent close out of observations
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 and or spreadsheet software, Microsoft Word, Excel, and PowerPoint
Understanding and experience utilizing the USP Compendia methods
Knowledge of Environmental Monitoring Programs
Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis.
Ability to travel up to 10%
Amerisourcebergen Corporation - Corporate