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curium jobs

Posted on 4th December 2019

Operations Quality Engineer II (Nights)

United States
Quality
Permanent
1383

About Curium

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 Operations Quality 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.

Essential Functions

  • 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.
NOTE: Position will require working a schedule that includes nights and weekends.

Requirements

  • Bachelor of Science in Biology, Chemistry, Life Sciences or related field required.
  • Minimum of three to five years of Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems.
  • 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.
Working Conditions:
  • 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.

Disclaimer

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.

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