Contractor) Senior Operations Quality Engineer

Company: Curium Pharma
Location: Noblesville
Posted on: February 25, 2021

Job Description:

(Contractor) Senior Operations Quality Engineer Date: Jan 18, 2021 Location: Noblesville, IN, United States 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 position is responsible for enforcing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures. The position will be responsible for providing confidence to management that product quality requirements will and have been met.-- Essential Functions

• Cross functional cGMP collaboration with Engineering, R&D, Chemistry, Compliance, and Production team members.
• Create, revise, and review cGMP Quality policies and procedures.
• Initiate, review, and monitor Quality Events (DEV, CAPA, CC, OOS).
• Provide initial GMP and Annual Refresher GMP Training.
• Review GMP protocols and reports.
• May participate in regulatory and client audits.
• Performs internal GMP audits.
• Conduct Laboratory Walk-Thru Audits.
• Provide On-The-Floor Production Support, as needed.
• Track and report KPP and Quality metrics.
• Analyze data to identify areas for improvement in the quality system (GMP QMS). Act as 2nd person verifier during production
• Assist in compiling and evaluating data for the Annual Product Review Report Requirements
  • Bachelor Degree in Life Sciences or Engineering.
  • Minimum of 5-8 years of Quality experience in a pharmaceutical manufacturing environment--
  • Significant experience investigating exceptions and other variances, using Quality Engineering Tools and Techniques (i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis)
  • 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 is strongly preferred.
  • Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant out comes.
  • Must have experience with statistical tools. Certification in Lean or Six Sigma preferred-- Working Conditions
    • Standard office environment, coupled with approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments.
    • Must be willing to wear a variety of personal protective equipment.
    • 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 sit, stand, walk, bend, push, pull, reach, and climb stairs without accommodation.
    • May be required to sit or stand for long periods of time while performing duties. 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.
      Job Segment: Operations Manager, Quality Engineer, Consulting, Engineering, Operations, Quality, Service

Keywords: Curium Pharma, Noblesville , Contractor) Senior Operations Quality Engineer, Engineering , Noblesville, Indiana