QA Deviation Specialist - Aseptic, Sterilization

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QA Deviation Specialist.

Position Type:

• Contract
• On-Site

Required:

• Bachelor's degree from an accredited college or university.
• 10+ years of experience working in Aseptic Processing facilities, with demonstrated expertise in manufacturing deviation investigations and technical report writing.
• Expert-level understanding of deviation management, manufacturing process investigations, Root Cause Analysis, and CAPA development and execution.
• Previous experience supporting or executing remediation plans in response to US FDA observations or regulatory requirements.
• Extensive Quality Assurance experience across multiple areas, including PQR, auditing, change control, complaints management, OOS investigations, batch record review, and documentation management.
• Experience with training programs, supplier quality management, and broader pharmaceutical quality systems within regulated manufacturing environments.
• Excellent written and verbal communication skills in English and other relevant languages, with strong collaboration, conflict resolution, and problem-solving abilities, and a demonstrated focus on KPIs and project goals. 

Reponsibitlies:

• Lead Minor, Major, and Critical Deviation investigations within assigned areas, ensuring thorough documentation and compliance with established quality procedures.
• Collect, review, and analyze relevant raw data, records, and supporting information to facilitate comprehensive investigations.
• Lead Root Cause Analysis (RCA) activities to identify probable root causes, assess potential product impact, and establish appropriate CAPAs with assigned owners and due dates.
• Perform deviation trending and data analysis to identify adverse trends, recurring issues, and opportunities for corrective action.
• Prepare, review, and finalize comprehensive investigation reports, ensuring accuracy, quality, and completion within established timelines.
• Develop and implement effective Corrective and Preventive Actions (CAPAs), including follow-up mechanisms to verify implementation and long-term effectiveness.
• Manage client communications, provide regular project progress updates, and report performance metrics to Project Leadership while ensuring timely approval and closure of investigation reports.