Full-Time
QA/QC Compliance Specialist
Posted on 7/31/2024
Azurity Pharmaceuticals
201-500 employees
Develops specialized formulations of medicines
Senior
Burlington, MA, USA
Hybrid work model: 2 days from home, 3 days in the office.
- BS degree in a science related field OR at least 5 years of applicable direct experience within the Quality Assurance field in lieu of BS Degree – required.
- Minimum 3 years’ experience in Quality Assurance in cGMP environment
- Minimum 3 years’ experience with Quality Systems (CAPA, Deviations, Change Controls, Complaints)
- Minimum 1 year experience in Quality Control in cGMP environment
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.
- Excellent organizational, verbal, and technical written communication skills.
- Very detail oriented
- Must be able to utilize problem solving skills and techniques to achieve problem resolution
- Review all QC protocols and align with operations schedule
- Review all stability protocols and reports
- Review data associated with all COTs incoming and finished goods, as needed
- Review all TM data as needed
- Review all QC Specifications
- Review QC Data Integrity
- Review all QC logbooks
- Participate in Area walk-thrus
- Review of all QC SOPs, Forms
- QA review and ownership for QC Deviations, CAPAs, Change Controls
- QA Review for OOSs, QLEs.
- Create, revise and review standard operating procedures (SOPs) as needed.
- Support Quality Systems tracking as needed.
- Protocol reviews, review of cGMP controlled documents as needed.
Azurity Pharmaceuticals develops specialized formulations of established medicines to meet the needs of patients often overlooked by other pharmaceutical companies. They focus on creating new dose forms, such as oral suspensions, that are easier to administer and absorb, particularly for those who have difficulty swallowing pills or require precise dosing. This approach 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. Their diverse portfolio includes products for various therapeutic areas, such as cardiovascular, central nervous system, and oncology, aimed at improving patient outcomes. Azurity's goal is to provide high-quality, innovative medicines that cater to unmet medical needs.
Company Stage
Growth Equity (Venture Capital)
Total Funding
$182.2M
Headquarters
Woburn, Massachusetts
Founded
2000
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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Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Company Match
401(k) Retirement Plan
Paid Vacation
Paid Holidays
Hybrid Work Options
Professional Development Budget
Tuition Reimbursement
Wellness Program