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(Contractor) Document Coordinator III

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

Process various site documents using computer-based systems, including, but not limited to, Standard Operation Procedures (SOPs), Standard Certification Methods (SCMs), Standard Testing Methods (STMs), Specifications and Batch Production Records. Catalog, scan, maintain, archive/file and retrieve various site documents/records, including, but not limited to, SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents and Validation Protocols.  Update various information containing indices (Excel, Access, etc.) as necessary.  Preparing logbooks and issuing logbooks and notebooks for use across the site.  Support Regulatory Affairs (US and Canada) by supplying current/historical documents, and assist in gathering information for audit events. Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance to applicable SOP’s, and cGMPs.  Assist with training of on job specific Document Control processes for new employees and temporary/contract workers.  Assist with audits (preparation, set-up, breakdown, and assist with the retrieval of requested documents).  Perform X1 searches using advanced search parameters.  Initial contract period is for 12 months.

Essential Functions

  • Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.
  • Ensure maintenance of their department, premises and equipment.

Requirements

  • Associates degree preferred, High School Diploma or equivalent is required.
  • Five (5) years (or equivalent experience) of documentation experience in a cGMP facility or in the medical transcription field is required.  Office administration experience will also be considered.
  • Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point. 
  • Willing to work occasional overtime and weekends as the business need dictates.
  • 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.
  • Ability to accurately type 45 words per minute.
  • Strong grammatical and document layout/design/formatting skills are mandatory.
  • Strong organization skills are essential.
  • Good communication skills.
  • Strong organization and time management skills.

 

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.
  • Responsibilities include the ability to lift up to 50 lbs., walk, bend, stoop, kneel, crouch, push, pull, reach, balance, and climb stairs and ladders with or without accommodation.  
  • Must be able to work outside of regular work hours.  
  • May be required to sit for long periods of time while performing duties. 
  • Must be willing to wear a variety of personal protective equipment.
  • Willingness to work in a team based environment. 
  • Close attention to detail required. 
  • Must possess good hand-eye coordination.
  • Willingness to work in a warehouse environment with no controlled climate.

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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