Department: Azzur Training Center - Raleigh, LLC
The Aseptic Trainer’s primary role is to support day-to-day activities within the Training Center, including supporting all functions related to creating and delivering training content with a focus on exceptional customer service. This individual will also support the Manager/Director of Training with the implementation of progressive competency-based technical training programs, ensuring consistency, compliance, and effectiveness within and across internal and external clients. Additionally, the Training Specialist will function as part of the training team to create, or update, training presentations and supporting material (i.e. procedures, visual aids, and hands on activities) to ensure compliance with industry best practices. This individual will also be responsible for maintaining client specific curricula and training portfolios. Training may take place in classrooms or cleanrooms, which requires the ability to successfully gown and work in an aseptic environment. Travel may be required to support client training projects. Additional responsibilities to be assigned as determined necessary.
HS diploma / GED required.
Bachelor’s degree preferred with a minimum of 5 years of Pharmaceutical / Biotech industry experience, including aseptic hands-on experience.
In lieu of a degree, candidates with a suitable number of years’ experience will be considered. 10+ years of industry experience in a Pharmaceutical / Biotech industry, with at least 2 years of hands on experience in aseptic manufacturing / processing environment, is preferred.
Required Work Experience:
5+ years of experience in cGxP environment, with demonstrated capability to train others.
2+ years of direct / hands-on experience working in an aseptic manufacturing environment (i.e. manufacturing, laboratory testing, etc.).
Direct experience training personnel in an aseptic environment is highly desirable.
Strong knowledge of Federal Regulations, U.S. Food and Drug Administration (FDA), current Good Manufacturing Practices (cGMPs) and other applicable industry guidance documents.
Extensive knowledge in aseptic gowning, aseptic manufacturing, and/or other aseptic techniques.
Familiarity with cleanroom processes including Cleanroom cleaning and maintenance, logbook completion, and industry legislation and guidance documents. Preferred Experience/Knowledge:
Direct experience and working knowledge of aseptic techniques and supporting equipment, including but not limited to: Isolators, BSCs, Laminar Air Flow Hoods, and/or RABS.
Experience performing aseptic manipulations and interventions.
Skills (Inc. Typical Mental Demands):
Must be fluent in English.
Comfortable presenting in a classroom setting to large groups.
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 for extended periods of time (2 – 4 hours).
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 technical information in one-on-one and in group situations.
Able to generate accurate and complete documentation utilizing cGDocP and cGMP principles.
Ability to follow instructions and prioritize assignments while working on various projects simultaneously.
Ability to respond to questions from internal/external customers/vendors at all levels including management.
Ability to interpret a variety of instructions furnished in written, oral, and diagram or schedule form.
Strong team player
Excellent 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!