Full-Time
Quality Assurance Compliance II
Confirmed live in the last 24 hours
Azurity Pharmaceuticals
201-500 employees
Develops specialized formulations of medicines
Mid, Senior
Burlington, MA, USA
Hybrid work model: 2 days from home, 3 days in the office.
- 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%)
- 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 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 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 commitment to quality and innovation has led to the development of numerous products that significantly benefit patients, positioning Azurity as a key player in the specialized pharmaceutical sector.
Company Stage
Series B
Total Funding
$182.2M
Headquarters
Woburn, Massachusetts
Founded
2000
Simplify's Take
What believers are saying
- FDA approval of Myhibbin™ highlights Azurity's capability to bring unique, patient-centric formulations to market, potentially increasing their market share.
- The acquisition of Slayback Pharma and Arbor Pharmaceuticals expands Azurity's development portfolio, promising a significant number of new medicine launches and enhancing their market position.
- Azurity's focus on underserved patient segments and innovative dose forms can lead to high patient satisfaction and loyalty, driving long-term growth.
What critics are saying
- Product recalls, such as the recent Zenzedi recall, can damage Azurity's reputation and lead to financial losses.
- The specialized nature of their products may limit their market size, making them vulnerable to market fluctuations and competitive pressures.
What makes Azurity Pharmaceuticals unique
- Azurity Pharmaceuticals focuses on developing innovative dose forms of established medicines, addressing unmet needs in the healthcare market, unlike competitors who may focus solely on new drug development.
- Their commitment to creating easier-to-administer formulations, such as oral suspensions, sets them apart by enhancing patient compliance and filling gaps in the pharmaceutical market.
- Azurity's broad therapeutic portfolio and FDA-approved proprietary products ensure they meet stringent regulatory standards, providing a competitive edge in quality and safety.