Kelly Services Sterility Manager in Denver, Colorado
Direct Hire or Temp to Hire
Sterility Manager responsibilities include, but are not limited to, the following :
Plans, directs and coordinates the operational activities of a Sterility laboratory/Controlled Testing Environments for routine testing of samples
Has personnel, quality and performance responsibility for department
Supervises the activities of the Sterility Assurance personnel
Manages and monitors the department budget including laboratory supplies and equipment
Maintains qualified staff by recruiting, selecting, training, and mentoring technologists
Supervises Sterility Assurance and Contamination Control Programs
Confirms quality systems are applied in the performance and documentation of laboratory work
Monitors production environment, processes and personnel for microbial and particulate contamination
Meets client's expectations for timeliness of laboratory studies as measured turnaround time
Develops, implements, and reviews procedures and protocols to assure compliance with internal and external regulatory agencies
Initiates and implements corrective actions as needed
Performs tasks, of moderate complexity, within planned schedules and timelines, supporting audits (FDA, ISO, Customer, Internal, etc.), actively leading or participating on project teams, ensuring documentation/procedural compliance and revises policies/procedures as required
Releases results for distribution, as needed and resolves non-conformances or deviations as they occur
Establishes department goals by gathering pertinent business, financial, service, and operations information, identifying and evaluating trends and options, choosing a course of action, defining objectives and evaluating outcomes
Keeps abreast of new technologies relating to sterility assurance and applies these technologies to the laboratory as necessary
Drives new test developments relating to Sterility Assurance testing
Works directly with the Director Microbiology to determine long-term goals and projections of Quality Control and Sterility Assurance testing laboratories.
Other duties as assigned
The ideal candidate would possess :
Considerable knowledge of the methods, materials, equipment, and techniques used in sterility testing
Demonstrated success in improving operational, quality, and safety performance
Strong problem solving skills
Ability to organize, communicate, teach, and work with others in an effective manner
Knowledge of federal, state, and local standards, regulations, guidelines and requirements effecting operations of a clinical reference laboratory
Ability to manage and schedule the work of others
Analytical thinking and communication skills
Bachelors of Science degree in Microbiology or other related discipline (Masters degree preferred)
8-10 years of related work experience, including 3-5 years supervisory experience
Regulatory experience required
Thorough knowledge of, but not limited to CLIA, FDA and USP standards/regulations
Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday through Friday from 8:00 am - 5:00 pm, with overtime as needed.
We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)