Overview
Senior QA Analyst Jobs in Cary, NC at Epic Games
## Mandatory Requirements (Must Have):
1. Education:
– Bachelor’s degree in Engineering, Chemistry, Sciences, or related field
– Current certifications in cGMP and FDA regulations
2. Experience:
– Minimum 5 years of experience in FDA-regulated pharmaceutical industry
– Demonstrable experience in complex quality investigations
– Solid experience in CAPA (Corrective Action and Preventive Action) management
– Proven track record in responding to FDA audit findings
3. Technical Knowledge:
– Mastery of Root Cause Analysis methodologies
– Deep understanding of FDA regulations for pharmaceutical manufacturing
– Solid knowledge of pharmaceutical quality systems
4. Skills:
– Bilingual (Spanish and English) – oral and written
– Advanced analytical capability for complex investigations
– Excellent technical documentation skills
## Essential Requirements (Should Have):
1. Technical Experience:
– Experience with electronic quality systems, preferably Veeva
– Knowledge of quality metrics and KPIs
– Experience in corrective actions management
– Familiarity with pharmaceutical manufacturing processes
2. Professional Skills:
– Ability to work independently
– Effective presentation and communication skills
– Experience in handling multiple simultaneous projects
– Ability to interact with all levels of the organization
3. Knowledge:
– Understanding of validation processes
– Knowledge of statistical analysis tools
– Familiarity with ICH guidelines
## Desired Requirements (Nice to Have):
1. Additional Experience:
– Previous experience with Infinity system
– Specific experience in solid and liquid drug manufacturing
– Previous experience in BMS or similar pharmaceutical companies
– Additional quality certifications (ASQ, Six Sigma)
2. Specialized Knowledge:
– FDA audit experience
– Knowledge of other electronic quality systems
– Experience in personnel training
– Familiarity with lean manufacturing
3. Additional Skills:
– Continuous improvement experience
– Knowledge of agile methodologies
– Mentoring skills
– Experience in organizational change management
4. Certifications:
– Six Sigma Black Belt
– Project Management Certification
– Specific pharmaceutical industry certifications
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
Job Types: Full-time, Temporary
Expected hours: 40 per week
Education:
Bachelor’s (Required)
Experience:
CAPA: 5 years (Preferred)
Root cause analysis: 5 years (Preferred)
technical documentation skills: 5 years (Preferred)
Project management: 5 years (Preferred)
Language:
Bilingual (Preferred)
Work Location: In person
Title: Senior QA Analyst
Company: Epic Games
Location: Cary, NC
