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(Contractor) Senior Quality Documentation Specialist

Company: CURIUM
Location: Maryland Heights
Posted on: May 28, 2023

Job Description:

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 Documentation Specialist is responsible for printing lot specific information on labels and other controlled labeling materials and staging labeling materials for production packaging and labeling activities. Essential Functions

  • Prints and verifies accuracy of printed information that will be issued to manufacturing for labeling and packaging operations. Prints test labels for manufacturing and validation purposes. Shares rotational on-call duties to issue labels during off-shift hours.
  • Retrieves labeling materials for kitting and maintains in a segregated manner.
  • Reviews procedures on a periodic basis to ensure completeness, accuracy, and compliance.
  • Communicates and investigates unexpected events and quality issues within the department.
  • Follows all applicable written procedures and assures alignment with regulation requirements.
  • Complies with internal and external regulations regarding the maintenance, labeling, and organization of electronic and paper documents.
  • Actively seeks, communicates, and assists in implementing quality process improvements as well as cost effective improvements in the department.
  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
  • Perform Safety walkthroughs and initiates safety improvements.
  • Perform minor maintenance of the area equipment. Ensure the maintenance of the department and premises.
  • Design and prints shipping labels for product samples.
  • Maintains Inventory - warehouse and label system checks, emergency printing, communication with IS, weekly meeting with manufacturing.
  • Perform periodic cycle counts on inventory.
  • Assist in labeling changes with Planning, Packaging, Regulatory Affairs and Packaging Engineering.
  • Assist with developing and/or modifying procedures related to Label Control in order to standardize methods, to ensure compliance, to implement improvements, and to reduce errors.
  • Assist with creation of weekly printing schedule, communication with manufacture planners, insurance of monthly plant attainment goals with respect to labeling needs, new products requiring labeling, and on -site inventory label levels. Requirements
    • Associate's Degree preferred or completion of 4 college level life science courses with labs, preferably chemistry/biology courses
    • 3 or more years of label control experience in a cGMP facility. General GMP/Quality experience will also be considered.
    • Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Outlook, and Power Point.
    • Willing to work occasional overtime and weekends as the business need dictates. Able to participate in the on-call schedule.
    • Ability to work well both independently and in a team atmosphere.
    • Demonstrated ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures required.
    • Strong organization skills are essential.
    • Good communication skills.
    • Strong organization and time management skills.
    • Proficient in use of Microsoft suite of products. Working conditions:
      • Standard office environment, coupled with approximately 80% time in radiopharmaceutical manufacturing
      • and laboratory environments.
      • 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.
      • 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.
      • Must possess good hand-eye coordination.
      • Responsibilities also include the ability to lift heavy objects (50 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach with or without accommodation.

Keywords: CURIUM, Springfield , (Contractor) Senior Quality Documentation Specialist, Other , Maryland Heights, Illinois

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