Job Description

We are seeking a seasoned QA Project Specialist with a strong background in quality remediation, CAPA management , and regulatory compliance to support strategic quality improvement initiatives across the organization. This role is pivotal in driving timely resolution of compliance gaps, ensuring robust root cause analysis, and implementing sustainable corrective and preventive actions (CAPAs). The ideal candidate will have 6+ years of experience in pharmaceutical Quality Assurance with a focus on GxP environments and regulatory remediation activities.

Key Responsibilities:

• Lead and coordinate remediation projects arising from regulatory inspections, internal audits, or quality system deficiencies.
• Manage the full lifecycle of CAPAs: initiation, investigation, root cause analysis (RCA), effectiveness checks, and closure.
• Drive cross-functional collaboration to ensure timely and effective execution of quality improvement plans.
• Prepare, track, and communicate progress of remediation efforts and CAPA activities to senior QA leadership and regulatory agencies, as needed.
• Analyze quality system data to identify trends and areas for proactive improvement.
• Support inspection readiness and actively participate in internal and external audits.
• Review and enhance quality system procedures and documentation to ensure compliance with FDA, EMA, and other global regulatory standards.
• Provide training and guidance to stakeholders on CAPA best practices, deviation handling, and remediation strategies.
• Support change control processes related to quality system updates and remediation plans.

Requirements

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Chemistry, Biology) or equivalent experience.
• Minimum 6 years of Quality Assurance experience in the pharmaceutical, biotech, or regulated life sciences industry.
• Demonstrated expertise in CAPA management, root cause analysis methodologies (e.g., 5 Whys, Fishbone, FMEA), and remediation planning.
• In-depth knowledge of GxP regulations and quality systems compliance (21 CFR Parts 210/211/820, ICH Q10).
• Strong project management skills with the ability to coordinate multiple stakeholders and deadlines.
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, or MasterControl.
• Experience managing responses to FDA Form 483 observations or Warning Letters.
• Familiarity with quality improvement frameworks (e.g., Lean, Six Sigma) is a plus.
• Advanced degree or certifications in quality, regulatory affairs, or project management (e.g., PMP, CQE) preferred.

Benefits

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)

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