Quality Engineer – cGMP CAPA Planning
As Quality Engineer you will work closely with cross-functional teams to investigate quality issues, outline results, and report findings, which will be reviewed by the customer regarding the manufacturing of products. You will work closely with all quality personnel and interface with R&D, Process Engineering, and Operations and Logistics.
Why work for this company?
- One of largest contract manufacturers of consumer goods
- Strong employee culture
- Proven history of growth with sales more than doubling over the last 5 years!
What will you be doing?
- Serve as point person for root-cause analysis and Corrective Action Procedures (CAPA)
- Write investigation reports for non-conformance and customer complaints, review with customers, and work towards mitigation
- Review investigation reports with customers
- Lead Quality Review Board (monthly cross-functional team) driving continuous improvement initiatives through identification of corrective and preventive actions
- Work cross-functionally with Manufacturing, R&D, Process Engineering, and Quality
- Other responsibilities or projects as assigned
What skills and experience are needed?
- Bachelor of Science in Science or Engineering with a minimum of three (3) years’ work experience; preferably in OTC/Cosmetic Manufacturing or Pharmaceutical Industry. Knowledge of 21 CFR 210/211 current Good Manufacturing Practices (cGMPs).
- Experience with quality investigations, root-cause analysis, and corrective action reports
- Effective communication skills (verbal and written)
- Adept with Microsoft Word and Excel
- Good Documentation Practices experience
- Ability to lead, take initiative and organize