Department: Azzur Training Center - Raleigh, LLC
The Aspectic Training Specialist’s primary role is to support on site client training activities and aseptic monitoring observation. This individual will function as part of a team to develop and incorporate proper aseptic gowning practices, cleanroom behaviors and aseptic techniques within an aseptic manufacturing area. Travel will be required to support client training projects. Responsible to function as part of a training team to create or update training programs to incorporate industry best practices. Training may take place in classrooms or cleanrooms, which requires the ability to successfully gown up and work in an aseptic environment.
Bachelor’s degree preferred Required Work Experience:
5+ years of experience in cGxP environment, demonstrated capability to train others, familiarity with aseptic processing concepts.
Experience working in an aseptic manufacturing environment, knowledge of aseptic gowning and aseptic techniques Required Knowledge:
Strong knowledge of Federal Regulations, U.S. Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMPs) and other applicable industry guidance documents. Preferred Knowledge:
Familiarity/experience with cleanroom cleaning and maintenance, logbooks, industry legislation and guidance documents.
Experience working with a RABS and performing aseptic interventions
Skills (Inc. Typical Mental Demands):
Must be able to speak, read, write and understand English.
Proficient in Microsoft Office: Word, Excel, PowerPoint / LMS and Google
Must be able to successfully gown for aseptic operations and pass gowning qualification.
Must be able to work in an aseptic environment in gowning attire
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations in English.
Ability to write reports, business correspondence, and procedure manuals. Ability to translate procedural information into training materials.
Ability to effectively present information in one-on-one and in group situations.
Able to generate accurate and complete documentation utilizing GDP and GMP principles.
Ability to follow instructions and prioritize assignments while working on various projects simultaneously.
Ability to interpret a variety of instructions furnished in written, oral, and diagram or schedule form.
Strong team player
Customer service/client relations
Attention to detail
Can work productively independently and with minor supervision
Self-motivated, flexible, dependable and available
Excellent organizational and time management skills
Ability to travel as required for project assignments
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!