Supplier Quality Engineer – GMP

To Apply for this Job Click Here

Summary of Position

This role is responsible for supporting the Quality Systems organization through conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.

Essential Functions

• Support and serve as investigator for Out of Specifications results.
• Identify and implement Corrective Actions.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
• Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc.
• Employ the use of quality tools (i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) in support investigations and special projects.
• Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives.
• Generate, execute and manage protocols for Method Validations, Equipment Qualifications Work with radioactive materials.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP’s.
• Maintain current knowledge of US and international regulations regarding Microbiology, Chemistry and cGMP’s.
• Provide support for regulatory agency (i.e. FDA, HC, EU, TGA, etc.) on-site audits.

Requirements

• Bachelor of Science degree in Life Sciences or Engineering required, or equivalent experience.
• Three or more years of relevant experience in a pharmaceutical/medical device manufacturing environment with strong understanding of and exposure to applicable quality systems required.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment preferred.
• Must have awareness of quality systems including Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
• Must have experience with statistical tools.
• Ability to do simple to complex math calculations, input data into the computer and analyze data as required.
• Must be proficient in use of Microsoft suite office products; Good computer skills, including utilizing personal computers and data entry programs.
• Good hands on, analytical, and problem solving and decision-making skills.
• Excellent writing and verbal communications skills.
• Ability to work independently and with others to accomplish goals and priorities.
• High level of energy and regular, consistent attendance.

LSNJN1451445AJ_1783450025

To Apply for this Job Click Here