Shire PTS Lead Investigator ABP in Cambridge, Massachusetts
Under general supervision the Lead Investigator will lead mainly Level 1 & 2 deviations and potentially Level 3 deviations.
Will manage closure within the established timelines for the manufacturing department.
Will conduct investigations of moderate scope and complexity to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.
Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.
Completion of Quality systems:
Investigate Manufacturing deviations, mainly Levels 1 & 2
Provide subject matter input for QC Out of Specification (OOS) and Out of Tolerance (OOT) events
May author impact assessment for calibration Out of Tolerance (OOT) events
May author impact assessment for Environmental Monitoring (EM) alert/action limit excursions
Escalate conflicts that arise.
Work cross-functionally to assess and analyze deviations to determine impact and root cause
Identify and initiate corrective and preventative actions for deviations
Track and identify Quality System and root cause trends and identify opportunities for operational improvements
Education & Experience Requirements:
Bachelor’s in Science or a related discipline
2-5 years related experience in the manufacturing and/or development of biologics, pharmaceuticals
Previous technical writing experience preferred
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.