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Quality Lab Associate III

 

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

 

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Job Function and Description

  • Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).
  • Conduct biological, chemical and physical analyses on raw materials, in-process and final containers or other samples collected from the Shire Georgia manufacturing facility.
  • May serve as mentor to other Laboratory positions. Provide training and work direction for Laboratory Associates positions as required. Manage work flow and laboratory release functions as specified by leadership.
  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems as needed.
  • Use sophisticated laboratory instrumentation such as UPLC/MS, ICP/MS, GC and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
  • Work on special projects / protocol testing that involves new methods and instrumentation. Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations. Conduct Laboratory investigations as directed by Lab leadership. 
  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
  • Perform laboratory audits as required. Audit and update, as required, SOPs.
  • Ensure employees are properly trained and/or qualified and periodically audited.  Ensure personal training requirements are met and that training records are current.
  • Perform routine walk-throughs and compliance checks to verify adherence to quality guidelines and appropriate laboratory technique.
  • Monitor testing techniques of laboratory personnel and review accuracy of records and documentation generated.
  • Assist in assay and equipment trouble shooting and ensure equipment maintenance and calibration is robust and completed on time. 
  • Lead and/or support problem solving sessions through application of the problem solving tools and methods to coordinate and/or lead investigation teams.  
  • Prepare, review and revise, as required, SOPs and specifications.  Write memos, reports, protocols, CPAs and other appropriate documentation for proper functioning of the lab operation.
  • Other duties, tasks or projects as assigned.

Education and Experience Requirements

         

  • Typically requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience.

Key Skills, Abilities, and Competencies

         

  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must have the ability to manage people, encourage teamwork and drive decisions.
  • Must be able to handle multiple projects concurrently.
  • Must have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.



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