Description
The QA Investigation Specialist plays a critical role in maintaining compliance and ensuring the integrity of manufacturing operations by executing thorough and timely investigations into deviations—primarily within downstream biologics processes. This individual will lead and support root cause analysis efforts, drive effective CAPA implementation, and collaborate across functional teams to uphold GMP standards and continuous improvement.
Key Responsibilities:
- Lead the end-to-end investigation and closure of deviations, including minor, major, and critical events, originating from manufacturing operations—especially focused on downstream biologics processes.
- Perform real-time deviation triage and provide quality oversight for immediate containment actions and initial impact assessments.
- Utilize advanced Root Cause Analysis (RCA) methodologies (e.g., 5 Whys, Fishbone, Fault Tree) to identify true root causes and contributing factors.
- Author comprehensive and compliant investigation reports in alignment with internal SOPs and regulatory expectations (FDA, EMA, etc.).
- Develop and implement robust, data-driven Corrective and Preventive Actions (CAPAs) to eliminate recurrence and enhance process robustness.
- Achieve and sustain >80% Right First Time (RFT) rate on deviation documentation and review cycle times within defined KPIs.
- Partner cross-functionally with Manufacturing, MS&T, Quality Control, and Engineering teams to gather data, analyze process trends, and ensure a holistic approach to investigations.
- Manage and prioritize multiple deviation cases and CAPA projects simultaneously while meeting strict deadlines.
- Facilitate investigation review meetings, present findings to stakeholders, and effectively manage differing viewpoints to drive consensus.
- Support audit and inspection readiness by maintaining thorough documentation and assisting with walkthroughs, interviews, and response preparation.
- Contribute to continuous improvement initiatives related to deviation and CAPA management systems.
- Perform additional QA-related duties as assigned to support the overall quality management system.
Requirements
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related discipline required; advanced degree preferred.
- Minimum 4–7 years of experience in GMP-regulated biologics or pharmaceutical manufacturing environment, with a strong focus on quality investigations.
- Proven expertise in deviation management, CAPA, and root cause analysis tools.
- Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and batch record review processes.
- Excellent written and verbal communication skills, with the ability to clearly articulate complex technical findings.
- Strong interpersonal skills and a collaborative mindset.
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)
- Paid Time Off (Vacation, Sick & Public Holidays)
