Ops Quality Eng II
On-siteRaleigh, North Carolina, United States
Raleigh, North Carolina, United StatesOn-siteFull TimeSmall
Full TimeSmall
Job Summary
Lead Quality Systems ownership by interpreting regulations, managing deviations, supplier quality, and product complaints, and driving CAPA projects. Execute root cause analysis and risk assessments using statistical tools like Minitab to resolve complex issues and implement continuous improvement initiatives. Support internal and external audits, develop sampling plans, and lead process mapping and FMEA activities to reduce defects. Collaborate with production teams and suppliers to establish best practices while maintaining compliance in a cGMP manufacturing environment.
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), FDA, EMA, USP, EP, and JP
- Experience in root cause analysis and risk analysis
- Good project management, problem solving, team building, and 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-motivated
- Action-oriented
- 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
Desired Qualifications
- B.S. Degree in Chemical Engineering is preferred, other degrees may be considered with relevant experience
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