Shire Sr. QA Specialist II- API in Exton, Pennsylvania

  • Perform independently across various GSC functions to ensure supplier quality of API manufacturing and supplier sites

  • Perform API batch record review/release

  • Review/approve deviations and investigations related to API manufacturing

  • Identify and resolve quality related issues that impact cGMP compliance, regulatory filings, continuity of supply and other risks to Shire products.Track and evaluate any nonconformance’s that occur during the manufacture of cGMP material.

  • Design action plans for more extensive investigations

  • Process/review/approve change controls related to Shire APIs

  • Review/approve contractor’s validation and qualification protocols and reports related to API

  • Conduct contractor audits to assure compliance to GMPs, regulatory filings (DMF, NDA, MAA, etc.) FDA, EU, and other applicable regulatory guidelines

  • Author and negotiate QTAs as needed.

  • Support Product, Quality System, Integration or other projects as assigned.

  • Other duties as assigned.

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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Reasonable Accommodations

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.