QA/QC Compliance Specialist

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Azurity Inc. is seeking a detail-oriented, dependable individual whose primary responsibility would entail supporting the QA review for QC documentation at Azurity. The QA Compliance Specialist will be primarily responsible for review of all QC documentation including protocols, reports, CofTs, QC data, OOSs, QC related Quality Systems.

DUTIES & RESPONSIBLITIES

• 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.

REQUIREMENTS:

• 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

Physical & Mental Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required

Benefits We Offer:

• Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
  • Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
  • Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement p