QC Laboratory Training Specialist

Location: Raleigh, NC
Department: Azzur Training Center - Raleigh, LLC

Job Description

Summary Objective of Position:

The QC Laboratory Training Specialist’s primary role is to train new analysts how to successfully execute

multiple microbiological and analytical methods. Additional responsibilities to be assigned as

determined necessary.

Essential Functions:

 Responsible for presenting technical information in a classroom/laboratory setting to personnel

of all backgrounds.

 Provide hands-on training to new hires on specific micro and/or analytical methodology /

equipment

 Deliver engaging and memorable learning experiences.

 Assist in developing training presentations, work instructions, checklists, and visual aids.

 Participate in regular team meetings to discuss business/client needs.

 Perform Cell therapy/immunotherapy analytical methods such as flow cytometry, cell

proliferation assays, mycoplasma testing (via PCR based methods), cell counting.

 Perform Microbiology assay and/or Sterility Testing including but not limited to endotoxin,

gram stain, growth promotion, and rapid sterility testing.

 Review laboratory generated data results.

 Troubleshoot methods and equipment as needed.

Education:

 HS Diploma / GED mandatory

 Bachelor’s degree required with a minimum of 2 years of Pharmaceutical / Biotech Industry

experience.

Required Work Experience:

 Microbiology OR Analytical experience required.

 2+ years of previous cGLP/cGMP-QC laboratory experience required including but not limited to

sterility testing, endotoxin, growth promotion, PCR.

 2+ years of experience in cGMP environment, familiarity with aseptic processing concepts is

preferred.

 Direct experience training individuals / groups on any subject.

 Hands on experience with various bioanalytical techniques including PCR, gram stain, sterility

testing.

 Experience in technical writing including Standard Operating Procedures (SOPs), protocols, and

investigations.

Required Knowledge:

 Strong knowledge of Federal Regulations, U.S. FDA, cGMPs, cGLP, USP, ICH, and other applicable

industry guidance documents.

 Proficiency with cGMP and cGDocP expectations.

 Strong understanding of Labware Laboratory Information Management System (LIMS)

 Ability to interpret a variety of instructions furnished in written, oral, and diagram or schedule

form.

 Extensive knowledge of microbiological OR QC analytical testing.

 

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 with assay development, method validation, technical transfers

 Some prior knowledge and working experience of cell therapy analytical methods with emphasis

on flowcytometry, mycoplasma (PCR-based), and cell counting.

 Experience with Rapid sterility testing (Bac T for example)

 Familiarity / experience with aseptic processing, gowning practices, logbooks, industry

legislation, and guidance documents desired.

Skills (i.e. Typical Mental Demands):

 Must be fluent in English.

 Proficient in Microsoft Office: Word, Excel, PowerPoint / LMS and Google.

 Effectively present technical information in one-on-one and in group situations. 

 Generate accurate and complete documentation utilizing cGDocP and cGMP principles.

 Follow instructions and prioritize assignments while working on various projects simultaneously.

 Respond to questions from internal/external customers/vendors at all levels including

management.

 Interpret a variety of instructions furnished in written, oral, and diagram or schedule form.

 Ability to work days, evenings, weekends, holidays, and extended shifts on an occasional basis.

Shift work is expected for some personnel.

Additional Qualifications: 

 Strong team player

 Creative and willing to try new approaches

 Flexible, adaptable, and capable of delivering in a fluid environment

 Excellent communication skills

 Strong ability to translate technical skills to others through training

 Strong 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

About Azzur

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!

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.

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