Aseptic Processing QA

Location: Raleigh Consulting
Department: Azzur of North Carolina, LLC

Job Description

Aseptic Processing QA

Candidates should include a good mix of mid to high experience levels with proficiency in aseptic processing, including gowning and working in controlled, classified spaces. Candidates will provide QA oversight during the execution of media fills and execution of EMPQs. Start date for this project is anticipated to be August 16th , 2021.

GENERAL REQUIREMENTS:

BS degree preferred
 2 years minimum but would like to see 2-5 years of industry experience that includes technical writing capability
 Ability to work 12-hour shifts including nights and weekends (0700 – 1900 or 1900 – 0700)
 50 hour work week expected at times
 Experience working in an aseptic environment within a GMP facility
 Strong written and verbal communication skills required
 QA knowledge / experience
 Regulatory (GDP/GMP) experience
 Strong attention to detail
 Excellent technical writing capability
 Ability to learn quickly, apply learned concepts and successfully execute directives
 Background screening and drug testing will be conducted


ASEPTIC REQUIREMENTS:

Provide QA support observing Aseptic manufacturing operators and EM analysts’ interventions within a Grade A (ISO 5) space
 Have solid understanding of basic aseptic processing requirements
 Document observed interventions during media fill
 Will have accountability for all filled media units throughout the media fill
 Specific daily tasks may change as requirements change
 Individuals must successfully go through all relevant SOP training on site, and complete gowning qualification for Grade A (ISO 5) spaces.
 Capability to work in a classified space wearing full aseptic gowning for hours at a time


PREFERRED EXPERIENCE:

Experience writing / executing EMPQ studies is a plus
 QA supervisory experience within an aseptic environment
 Fill/Finish experience with various components in an aseptic environment
 Technical background in Science, Engineering, Chemical Engineering, and Microbiology


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 is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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