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
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.
Execute activities as part of the Quality Control Investigation team to ensure the safety and reliability of Shire products are in compliance with quality and regulatory requirements. Complete robust investigations that determine accurate root causes and effective corrective and preventive actions that mistake proof against the root causes. Support Contamination Control Master Plan (CCMP) initiatives. Interface with Manufacturing, Quality Assurance, and Quality Systems to support product fulfillment and regulatory requirements. Continuously drive the application of Lean and Six Sigma principles to the floor level through activities such as Kaizen, Six Sigma projects and VIPs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Conduct thorough investigations and complete associated nonconformance events (CAPA, OOL, and OOS) in an effective and timely manner in accordance with cGMP and quality systems. Ensure extension requests are completed in a timely manner.Conduct associated investigations to meet product fulfillment dates.Work closely with other Quality, manufacturing, and support departments to conduct investigations, determine appropriate corrective actions, and drive closure of non-conformances.Support and/or lead problem solving sessions through application of various problem solving tools and methods. May lead routine investigations and support complex investigations (such as CAPA investigations).Conduct investigative audits of manufacturing areas and/or personnel as required.Perform investigative sampling of manufacturing areas as required.Prepare and present trend analyses to management during routine operating mechanisms as directed.Support Contamination Control Master Plan (CCMP) initiatives for environmental and product Bioburden to organize and streamline all of the required contamination control elements and mitigate risk to product.Support laboratory audit readiness efforts with understanding of FDA, Shire, and other regulatory and quality requirements.Maintain data integrity and ensure compliance with company SOP’s and specifications, FDA, GLP, QSR, and cGMP regulations.
Advanced laboratory skills, basic knowledge of statistical methods.Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.Strong technical problem solving skills.Strong organizational and time management skills, and ability to handle multiple tasks and deliver results within set timelines.Basic understanding of manufacturing and facility processes.Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.Must be able to communicate effectively (verbal and written) with supervisors and peers and be able to work cross-functionally with other groups.Evidence of general presentation skills required, good presentation skills are a plus. Must be able to understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.Knowledge of chemical and biological safety procedures.Computer literate.
Must be able to learn new computer systems and programs in a timely manner.
EDUCATION AND/OR EXPERIENCE:
Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years’ experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years’ experience.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law – Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.