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(Contractor) Sr. Quality Systems Analyst

Date:  Sep 20, 2021
Location: 

Maryland Heights, MO, 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 Senior Quality Systems Analyst contractor will work in support of the Quality Systems organization at the Maryland Heights, Missouri facility.  The position is responsible for the administration, development, and support of the Quality Computer Systems in compliance with applicable regulations.  Quality System Analysts have a responsibility to support all areas of the site for overall compliance and adherence in relation to the site Quality Computer Systems.  Initial contract period is for 12 months.

Essential Functions

  • Provide application technical support, including advanced investigation/ troubleshooting and timely resolution of system issues.
  • Develop system workflows and implement enhancements to existing applications.  
  • Define system requirements, priorities, and viable alternatives. 
  • Support interfaces with external applications.
  • Work with vendors to establish and maintain quality software systems.
  • Lead the delivery of quality software through effective design and configuration.
  • Responsible for the full system life cycle from design, configuration, testing, validation, implementation to maintenance and application support.
  • Act as a project lead and direct systems analysts.  Provide leadership and coordination on projects assigned to systems analysts.  
  • Assist in developing user documentation and departmental policies and procedures that impact the use of application systems. 
  • Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.

Requirements

  • Bachelor Degree in Science or related field. Master Degree preferred.
  • Minimum of 5 to 8 years of experience in Systems analysis and/or Business analysis with project management or leadership responsibilities.    
  • 3-5 years of experience in the pharmaceutical industry.  
  • Must have working knowledge in information systems, including familiarity with LIMS and Quality System Management applications, sufficient to use and support on-line, interactive applications and to plan and perform medium- to large-scale computer projects.
  • Must have working knowledge with Oracle client and/or Microsoft SQL.
  • Must have working knowledge of Quality System Software Development Life Cycle (SDLC) management, including data and configuration change management, data integrity, system security, and disaster recovery.
  • Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems
  • Working knowledge of cGMP guidelines.
  • Proficient in use of Microsoft suite of products.
  • Must have ability to exercise independent judgment in planning, organizing, and performing systems analyst tasks. Some independent judgment required in setting priorities of tasks among multiple assigned projects.
  • 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 possess strong problem solving, decision making, verbal and written communications skills.
  • Results-oriented, able to make decisions and prioritize work per business needs in a fast paced environment. 
  • Good analytical and problem-solving skills.
  • Strong communication, organization and time management skills.
  • An understanding of the pharmaceutical industry and its unique business and social responsibilities
  • A thorough understanding of the requirements outlined in FDA 21 CFR Part 11

 

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.
  • Candidate must be willing to wear a variety of personnel protective equipment.  
  • Must possess good hand-eye coordination and be able to stand for long periods of time as required by production demand.
  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.  
  • 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 a team based environment. 

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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