Quality Assurance Specialist II

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.

The position will support the operation of a new, state-of-the-art plasma fractionation facility that will bring Shire additional capacity for testing, purification and fill finish for its biologic medications.

Responsible for timely release of production lots within the QA fractionation organization.
Responsible for providing Quality Assurance support for Fractionation manufacturing process as needed. Provides Quality oversight of operation activities, review batch related document.  Use of Electronic Batch Management (EBM) system.  Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practices.   Interacts frequently with functional peer, and provide coaching, training and development of subordinates. The incumbent will demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving.

Essential Duties and Responsibilities:

  • Review documentation for accuracy and compliance to procedures, and release and reject as appropriate.
  • Review electronic  batch records, identify nonconformance?s and participate in investigation and Corrective and Prevention Action(CAPA) activities
  • Provide training and coaching to local employees and others as needed on relevant area(s). 
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
  • Participate in QA multi-site projects in the role of contributor, coordinator or lead.
  • Other duties, tasks or projects as assigned.

Working Environment:

  • May be required to travel to local and international work locations for extended periods of time for training.


Education and/or Experience:

BS in Science / Business or equivalent.  3-5 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.

  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a team player with good problem solving, and good verbal and written communication skills.
  • Must have the ability to encourage teamwork and drive decisions.
  • Must be able to handle multiple projects concurrently.
  • Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required
  • Knowledge of TrackWise, Delta V and Electronic Batch Record Management preferred  
  • Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

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