Full-Time

Quality Assurance Compliance II

Posted on 7/31/2024

Azurity Pharmaceuticals

Azurity Pharmaceuticals

201-500 employees

Develops specialized formulations of medicines

Biotechnology
Healthcare

Mid, Senior

Burlington, MA, USA

Hybrid work model: 2 days from home, 3 days in the office.

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Management
Quality Assurance (QA)
Requirements
  • Bachelor’s degree or at least 4 years of applicable direct experience within the QA field in lieu of degree.
  • Minimum of 3 years in a GMP environment
  • Minimum of 3 years’ experience with Supplier Quality and Audits
  • Minimum of 3 years’ experience with CAPA/Deviations/Change Control
  • Must be able to utilize problem solving skills and techniques to achieve problem resolution.
  • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance to meet timelines while ensuring cGMP and regulatory requirements.
  • This position does require some traveling (10%)
Responsibilities
  • Supplier Quality Management
  • Perform external Audits (travel required)
  • ICAR ownership, management, and closure
  • VCN program ownership and follow through.
  • Perform internal audits and follow through on findings.
  • Participate with onsite walk-thru audits for compliance.
  • Management of Training System-uploading and linking trainings.
  • Monthly training metrics
  • QA Reviewer for Deviations, CAPAs and Change Controls
  • Follow up with multiple stakeholders to ensure timely completion of CAPAs and Deviations
  • SOP creation and reviews
  • Protocol reviews
  • Provide support during audits and works to address any quality gaps and identify any improvements that can be implemented.
  • Drive continuous improvement initiatives across supplier quality and training.
Azurity Pharmaceuticals

Azurity Pharmaceuticals

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Azurity Pharmaceuticals develops specialized formulations of existing medicines to meet the needs of patients who are often overlooked by other pharmaceutical companies. Their products include oral suspensions and other dose forms that are easier to administer, particularly for those who have difficulty swallowing pills or need precise dosing. This focus on creating accessible and effective medications enhances patient compliance and addresses gaps in the pharmaceutical market. Azurity serves healthcare providers, hospitals, and pharmacies, generating revenue through the sale of FDA-approved proprietary medicines across various therapeutic areas, including cardiovascular, central nervous system, and oncology. Their goal is to improve patient outcomes by providing high-quality, innovative medicines tailored to specific medical conditions.

Company Stage

Growth Equity (Venture Capital)

Total Funding

$182.2M

Headquarters

Woburn, Massachusetts

Founded

2000

Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for personalized medicine aligns with Azurity's specialized dose forms.
  • Increasing chronic diseases boost need for Azurity's innovative drug delivery systems.
  • FDA's focus on novel formulations benefits Azurity's product pipeline.

What critics are saying

  • Product recalls, like Zenzedi's, can damage brand reputation and cause financial losses.
  • Integration challenges from Slayback Pharma acquisition may disrupt operations.
  • Reliance on FDA approvals means regulatory delays could impact product launches.

What makes Azurity Pharmaceuticals unique

  • Azurity focuses on innovative dose forms for overlooked patient needs.
  • Their FDA-approved products ensure safety and efficacy in specialized formulations.
  • Azurity's acquisition of Slayback Pharma enhances its development and launch capabilities.

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