Senior Quality Control Analyst Lab Support

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.

  • Maintain the network of instruments and client systems per 21 CFR requirements, including but not limited to account management, troubleshooting, training, security, group policies and instrument lifecycle.
  • Maintain data integrity, including but not limited to performing assessments, backup and recovery, periodic reviews and disaster recovery per FDA guidelines and company SOP?s.
  • Write and execute IOQ?s, PQ?s and related documentation for new instrumentation and re-qualification as required for existing instruments according to laboratory needs.
  • Stay current in the field of laboratory instrumentation and data integrity to ensure compliance with company SOPs, Specifications, FDA, GLP, QSR and cGMP regulations.
  • Assist in the building and maintenance of custom queries and reports, including but not limited to using Oracle SQL Developer and Crystal Reports for departmental indicators, trending and charting.
  • Follow continuous improvement practices, including but not limited to QLP, 5S, LEAN, etc.
  • Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Perform laboratory instrumentation audits as required. Review and update, as required, software administration SOPs.
  • Work within the LIMS system in an administrative role, including but limited to user/role management, troubleshooting issues, assisting end users.
  • Assist analysts in troubleshooting issues via remote connection after business hours as needed and required.
  • May perform other duties as assigned.


  • Strong technical problem solving skills in the area of regulated 21 CFR laboratory instrumentation and data integrity.
  • Knowledge of laboratory instrumentation and software, including but not limited to Empower, LIMS, Chromeleon and OpenLab.
  • Excellent computer skills, including but not limited to Microsoft Word, Excel PowerPoint and Access. Knowledge of Crystal Reports and SQL Developer a plus.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills with supervisors, peers, vendors, and technical support.
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Must demonstrate effectiveness in ability to train others.
  • Availability to the laboratory network via remote connection after business hours as needed and required.


Bachelor?s Degree in Information Technology or Chemistry or Biological Sciences with 2-5 years? experience, or Master?s Degree in Chemistry, or Biological Sciences, with 0-3 years? experience.

Appropriate additional certifications may be required pursuant to state or federal regulatory requirements

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.