Posted on 14th November 2018
Principal Quality Operations Engineer
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Principal Quality Operations Engineer position is responsible for the oversight and primary SME for all quality systems used for our business. This position requires strong technical and training skills for site quality systems. The position reports directly to the Quality Operations Manager.
Knowledge in pharmaceutical quality systems with proficiency in quality oversight of a minimum of 50% of the following: Stability, Change Control / Regulatory, Supplier Relations, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Document Control and Annual Product Reviews.
- Take a leadership role for site/corporate development and maintenance of facility’s quality systems and procedures.
- Review and approve Change Control/Management Documents involving product or process changes.
- Key personnel for FDA or other regulatory agencies for on-site audits.
- Provides New Hire cGMP Training.
- Drive for resolution of product complaints, exceptions, corrective actions, and/or safety issues.
- Assemble, analyze and report QA system data to ensure regulatory compliance, identify trends and to identify areas of improvement.
- Conduct quality audits and develop and assess subsequent corrective action recommendation(s).
- Developing procedures, statistical evaluations, and remediation of systems.
- Ability to adapt quickly in a fast paced dynamic environment.
- Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
- Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP’s.
- Ensure the maintenance of the department, premises and equipment.
- Additional areas of responsibility may include developing specifications test methods, sampling plans and standard operating procedures; providing quality system training; actively participating in Material Review Board meetings; and assisting Corporate Product Monitoring in preparation of regulatory submissions.
- Bachelor of Science in Biology, Chemistry, Life Sciences or related field required
- Minimum of 8 to 12 years Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
- Minimum of 3-5 years of experience in supporting on-site inspections for regulatory agencies.
- Significant experience investigating exceptions and other variances.
- Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
- Working knowledge of cGMP guidelines and their application in a controlled aseptic environment.
- Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
- Must have experience with statistical tools.
- Proficient in use of Microsoft suite of products.
- Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be willing to wear a variety of personal protective equipment.
- Willingness to work in a team based environment.
- Close attention to detail required.
- 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.
- 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.