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Quality Engineer

Branchburg, New Jersey, United States
March 14, 2018

Job Responsibilities:

• The Quality Engineer is responsible for completion of Annual Product Reviews inclusive of Statistical Process Control (SPC) analysis.

• Trend Analysis of deviation and complaint investigations, and associated corrective actions. The development and execution of continuous improvement projects; and maintenance of defined QA metrics.

• Specifically, the successful candidate will: Prepare Annual Product Reviews in support of FDA / GMP requirements;

• Perform Statistical analysis for the identification of trends among deviation investigations;

• Identify and Execute continuous improvement projects applying Lean Six Sigma principles; Identify product related CAPA plans (corrective / preventive actions).

• Support process related deviation resolution. Provide cross-functional support to other departments, as necessary; Identify quality / compliance related issues.

• Maintain defined department / site metrics and report to senior management; and Maintain department SOPs and policies.

Job Requirements:

• The position requires a Bachelor’s Degree in Engineering or Sciences with a minimum of 5-7 years experience in Process Development Process Improvement, Quality Control, or Manufacturing within the pharmaceutical industry.

• Expertise in troubleshooting or developing various unit operations and/or analytical methods is beneficial. The ideal candidate will be well situated to knowledgeably discuss unit operations and analytical methods, be capable of performing complex statistical analyses using MS Excel and Statistical Analysis Packages, and write compelling evaluations of those analyses.