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Shire Senior Quality Assurance Specialist in Lexington, Massachusetts
This position provides senior level support of the QA Validation functions for the Massachusetts Biologics Operations with primary support at the Lexington location.
Provide quality oversight of facility and equipment commissioning and qualification activities.
Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
Support cleaning validation efforts.
Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
Use project management skills to drive results and achieve expected timelines and outcomes
Represent the QA-Validation team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements.
Support regulatory inspections and inspection readiness activities
50%: Provide quality oversight and ensuring GMP compliance for engineering and validation deliverables related to site and capital projects (Compliance, Improvement, Technology Transfers, etc.) including requirements definition, specification, engineering design, qualification, process validation and change management
20%: Serve as point of contact for customer groups to identify project needs and ensure practices are consistent with quality and regulator standards
15%: Support site validation maintenance and remediation activities
10%: Providing support during internal and agency inspections and performing quality assessment for all site based engineering changes
5%: Develop and maintain good working relationships with customer groups and support an environment of teamwork and collaboration
Education and Experience Requirements
5+ years of industry experience in a pharmaceutical/biotech GMP environment
BS in Engineering and or Science and a minimum of 3 years of project management and or project support experience with increasing responsibility in the areas of Quality Assurance
Knowledge of FDA and EMEA regulations, process validation, and a working knowledge of statistical analysis and root cause analysis is required
Excellent interpersonal skills and strong oral and written communication
Other Job Requirements
The ability to work at all MA site locations as required. The person in this role will be required to carry an iPhone and be on call as required to support validation activities.
Notice to Employment / Recruitment Agents:
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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, gender identity, 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.