Operations Quality Engineer II
On-siteRaleigh, North Carolina, United States
Job Summary
Interpret and apply applicable regulations and quality systems in a cGMP manufacturing setting to support process and quality engineering across the facility. Lead investigations for deviations, supplier quality issues, product complaints, and OOS results, utilizing statistical tools to analyze data, identify root causes, and develop corrective actions. Manage continuous improvement activities including CAPA projects, risk analysis (FMEA), and process mapping to define critical control points. Provide support for internal and external audits, assist in supplier quality oversight, and implement best practices through benchmarking and kaizen initiatives. Work within production teams to develop data trending models and drive quality-minded efficiencies while maintaining compliance efforts for the site.
Required Qualifications
- B.S. degree in Chemical Engineering
- 1-5 years' experience in QA or a pharmaceutical manufacturing environment
- Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10)
- Experience in root cause analysis
- Experience in risk analysis
- Good project management skills
- Problem solving skills
- Team building skills
- Negotiation skills
- Strong technical, oral, and written communication skills
- Able to speak, read, and write the English language
- Knowledge of Six Sigma Tools
- Ability to plan and execute tasks on multiple projects simultaneously
- Self-motivation
- Action-oriented mindset
- Technical Skills
- Problem Solving
- Informing
- Organizing
- Command Skills
- Action Oriented
- Conflict Management
- Customer Focus
- Timely Decision Making
- Functional / Technical Skills
- Presentation Skills
- Priority Setting
- Dealing with Ambiguity
- Written Communication
- Must be able to wear the required Personal Protective Equipment (PPE)
- Must complete some routine assignments in plant and non-air conditioned production environment
- Position may require some travel
Desired Qualifications
- B.S. degree in Chemical Engineering is preferred, other degrees may be considered with relevant experience
- Must strive for continuous improvements in all work activities
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