Senior Supplier Quality Engineer

Summary of Position

The Senior Quality Systems Engineer position is located at the Maryland Heights manufacturing facility and is responsible for assisting with the Supplier Quality Program.  The position is responsible for assisting with Supplier Quality Management, including but not limited to the following:  supplier evaluations, Quality Agreements, corrective actions, vendor changes, metrics, filing and scanning documents.  The position is also expected to participate in the internal auditing program and to support site regulatory inspections and customer audits, as applicable.

Schedule:  Monday – Friday 7:30 am – 4:00 pm

Essential Functions

• Maintain the Supplier Quality Program in compliance with applicable regulations by working with suppliers to maintain a compliant status.
• 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.).
• Conduct supplier evaluations, including assessments via questionnaire and audits, as applicable. 
• Issue supplier complaints and drive for resolution and corrective action. 
• Develop and maintain Supplier Quality Agreements
• Perform initial assessment of vendor changes, route for functional reviews, and track to completion.
• Report on Supplier Quality metrics and perform statistical evaluations to identify trends.
• Provide leadership and coordination on assigned projects.
• Participate in Internal Audits and assess subsequent corrective action recommendations.
• Provide support for FDA or other regulatory inspections and customer audits.
• Perform filing and scanning of documents.
• Execute and deliver on assigned project tasks in accordance with established timelines. 
• Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.

Requirements

• Bachelor of Science degree in Life Sciences or Engineering required.
• 5 or more years of relevant Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
• Must have working knowledge in Supplier Quality Management, Supplier Auditing, Supplier Assessment, Supplier Quality Agreements, and Corrective Action.
• Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
• Must have a working knowledge of ISO standards, especially ISO 9001 and ISO 13485.
• Must have strong technical knowledge in pharmaceutical quality systems with proficiency in the following: Change Control, Internal Auditing, Corrective Action Program, Deviation and Complaint investigations, and Document Management.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation, equipment, processes, and facility systems.
• Must have experience with statistical tools.
• Proficient in use of Microsoft suite of products.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.  
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.  
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.