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Azzur Group
Burlington, MA | Full Time
$77k-95k (estimate)
3 Months Ago
Quality Assurance Specialist II
Azzur Group Burlington, MA
$77k-95k (estimate)
Full Time | Business Services 3 Months Ago
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Azzur Group is Hiring a Quality Assurance Specialist II Near Burlington, MA

About Azzur Cleanrooms On Demand™As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on Demand™ mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.
The Quality Specialist II Will Execute Tasks Inaccordance With The Azzur Cleanrooms On Demand (ACoD) Quality Management System; Includingbut Not Limited To
  • Environmental monitoring program review and related investigations
  • Processing deviations and CAPA records
  • Reviewing and approving site specific forms
  • Recommending and implementing site improvements
  • Compiling quality related metrics
  • Approving disposition of client raw materials
  • Scanning required client documents to meet quality agreements
  • Supporting internal/external audits as needed
Education
  • Bachelor’s degree or higher in a scientific discipline, or equivalent experience
Work Experience
  • 1-2 years experience in Quality roles or one with related job skills; 3 years Quality experience preferred
  • GMP and Cleanroom experience is highly preferred

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$77k-95k (estimate)

POST DATE

06/30/2024

EXPIRATION DATE

08/24/2024

WEBSITE

azzur.com

HEADQUARTERS

HATBORO, PA

SIZE

200 - 500

FOUNDED

2010

CEO

MARK O DONNELL

REVENUE

$50M - $200M

INDUSTRY

Business Services

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About Azzur Group

From Discovery to Delivery, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the worlds leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain. Vision: To be the premier choice of clients... and talent across our services. Mission: We will lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to Delivery. Core Values: Put others first Have courage to take action Take personal responsibility Have Fun! More
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