Posted on 30th June 2020
Senior Quality Systems Engineer
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
The Senior Quality Systems Engineer position is responsible for oversight, administration, and execution of the Supplier Quality Program in compliance with applicable regulations. The position is responsible for Supplier Management, including supplier audits, assessments, Quality Agreements, and corrective actions. The position will require participation in the internal auditing program and supporting site regulatory inspections and customer audits.
- Manage the Supplier Quality Program in compliance with applicable regulations by working with suppliers to maintain a compliant status.
- Conduct supplier audits, evaluations, and assessments
- Issue supplier complaints and drive for resolution and corrective action.
- Develop and maintain Supplier Quality Agreements
- Perform Quality review and approval of Change Controls.
- Perform statistical evaluations to identify trends and report on Supplier Quality metrics
- Conduct internal quality audits and develop and assess subsequent corrective action recommendations.
- Provide support for FDA or other regulatory inspections and customer audits.
- Provide leadership and coordination on assigned projects.
- Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.
- Bachelor of Science degree in Life Sciences or Engineering required.
- Minimum of 5-8 years Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
- Minimum of 2-3 years of experience in Supplier Quality Management and supplier auditing.
- Minimum of 2-3 years of experience in supporting on-site regulatory inspections.
- 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 strong technical knowledge in pharmaceutical quality systems with proficiency in the following: Stability, Change Control, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Regulatory Affairs, Document Management, and Annual Product Reviews.
- Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation, equipment, processes, and facility systems.
- Must have working knowledge of Change Management.
- Must have experience with statistical tools.
- Proficient in use of Microsoft suite of products.
- Must possess strong problem solving, decision making, verbal and written communications skills.
- Must be results-oriented, able to make decisions, and prioritize work per business needs in a fast-paced environment.
- Must have ability to exercise independent judgment in planning, organizing, and performing tasks.
- Must have ability to communicate, motivate, and organize projects among a broad spectrum of personnel throughout the network, frequently under deadline pressure.
- Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
- Must have ability to communicate with and positively influence broad and diverse populations within and outside the organization.
- Standard office environment coupled with time in radiopharmaceutical manufacturing and laboratory environments
- Must be willing to wear a variety of personal protective equipment
- Willingness to work in a team-based environment
- May be required to sit or stand for long periods of time while performing duties
- Must be able to work outside of regular work hours
- 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 also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation
- Must possess good hand-eye coordination
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Posted on 18th June 2020
Posted on 11th November 2019