Job Description
Assist in the oversight, evaluation, and corrective action of all production and supplier quality related issues, including outside processes and suppliers with an emphasis on injection molding.
Additionally, generating reports, memos, files, and presentations necessary to communicate the issues for the items listed above according to site procedures. Create, schedule, execute and summarize Quality Engineering related protocols. Assist in the process of gathering, interpret and apply statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations. Assist in training personnel on unique defects, protocols, measurement techniques and procedures. Able to demonstrate and use as necessary all relevant lab measurement devices.
ROLE RESPONSIBILITIES:
- Designs, executes Quality Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with manufacturer and Pfizer specifications with current Good Manufacturing Practices.
- Responsible for quality and process related issues for outside suppliers.
- Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters.
- Capable of singular project management (within the realm of Quality Engineering) management/direction for smaller scope Quality Engineering Plans.
QUALIFICATIONS:
- Bachelor’s Degree in an Engineering related field, with four to ten years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience in injection molding preferred.
- Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory.
- Thorough knowledge of cGMPs and internal SOPs related to Quality Validation. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
- Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CA/PA) for recommendation to management..