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Microbiology Laboratory Supervisor

 PharMEDium, an AmerisourceBergen Company is the leading provider of pharmacy-outsourced, ready-to-use compounded sterile preparations (CSPs).PharMEDium's Mission is to be the preeminent provider of choice for pharmacy outsourced sterile intravenous admixture compounding services, supporting the triad of care that exists between patients, clinicians and pharmacists,  Our goal is to provide the highest quality service, facilitating the best clinical care and patient safety. This role is a 3rd Shift, working 8 hour shifts, overnights Sunday night through Thursday morning.    What you will be doing  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   What your background should look like (minimum qualifications)   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%  Nice to haveKnowledge of Aseptic Technique A PLUS! What AmerisourceBergen offers We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population. Healthcare for associates and eligible dependents, same-sex and domestic partners Paid time off, including vacations and holidays Paid volunteer time off Life insurance and disability protection Pet insurance Employee Stock Purchase Program Retirement benefits and more... Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit. 00001S2M
Salary Range: NA
Minimum Qualification
8 - 10 years

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