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Quality Assurance Specialist

Date:  Sep 28, 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 Quality Assurance Specialist position reports directly to the Director-Quality Compliance.  The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.  

Essential Functions

  • Write, revise, review, and approve site procedures and policies.
  • Review and approve investigations and associated CAPAs
  • Participates in regulatory agency (i.e. FDA, etc.) inspections 
  • Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented 
  • Assemble, analyze and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement
  • Review Batch Records and provide final product disposition
  • Conducts internal audits of GMP Quality Systems and sub systems
  • Aide in assessing risk during Vendor Qualifications or Material Assessments
  • Conducts incoming material disposition
  • Document Control, Training, Quality Systems back-up and key trainer
  • Reviews and assesses in-house solution preparation and external material testing
  • Conducts Vendor Qualification and reviews
  • Review and compile the Annual Product Quality Review
  • 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.

Requirements

  • Bachelor Degree in Life Sciences or related field
  • 3-5 years of GMP Quality experience in a pharmaceutical manufacturing environment 
  • 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 regulations and 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

 

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.
  • Corrosive, flammable, and toxic material, all which are normally handled in the plant, pose potential leak points for slips, trips and falls.  Extra care must be taken while navigating the site.
  • Must be able to physically negotiate stairs and evacuation ladders without accommodation, to wear and operate safety equipment, enter vessels, inspect equipment, etc.
  • Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
  • Willingness to work in a team based environment. 
  • Close attention to detail required. 
  • May be required to stand or sit for long periods of time while performing duties. Must be able to stand 8+ hours a day.
  • Responsibilities also include the ability to lift heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation.  
  • Must possess good hand-eye coordination.
  • Exposure to high noise levels.
     

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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