A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
Director of Microbiology System One - 3.5 Boca Raton, FL Job Details 17 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Program management Cleanroom environmental monitoring Team leadership Microbiology testing Contamination control GMP Manufacturing facility experience Sterile field contamination management Leading team collaboration initiatives Regulatory/legal compliance standards in production Environmental monitoring Biomedical regulatory compliance Microbiological analysis Microbiological testing for sterile processing Legal compliance Method validation Pharmaceutical manufacturing facility experience
Full Job Description Job Title:
Director of Microbiology Location:
Boca Raton, FL Type:
Direct Hire Work Model:
Onsite Overview Join a fast-growing sterile injectable manufacturing site as the onsite Director of Microbiology, leading sterility assurance, microbiology testing while driving audit readiness and regulatory compliance! Responsibilities Manage and supervise microbiology team Oversee microbiological testing, EM, sterility assurance, and media fills Ensure regulatory compliance and handle deviations/CAPA/change controls Requirements Bachelor's, Master's, or PhD in a relevant field 8+ years of microbiology experience in a GMP environment 5+ years of recent GMP sterile injectable experience 5+ years of management experience 5+ years of method development & validation experience Participation in audits and direct communication with regulatory bodies (FDA) Aseptic & Sterility Assurance expertise Sterility assurance and contamination assessment expertise Environmental Monitoring Program Management GMP/FDA Regulatory Compliance and team leadership Candidates must be legally authorized to work in the United States and will not require current or future employer sponsorship for employment System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #
