At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Title: Senior QA Specialist - Supplier Quality
Location: Onsite, Philadelphia, PA 19112
Schedule: M-F 8am-5pm
Type: Direct/Permanent
Compensation: Competitive salary with an excellent benefits package
Start date: Immediate
Overview:
Join our dynamic team as a QA Specialist - Supplier Quality for a Contract Development and Manufacturing Organization (CDMO) will play a crucial role in ensuring the highest standards of quality and compliance are maintained throughout the cell and gene therapy manufacturing process. The QA Specialist will collaborate with cross-functional teams to implement and maintain robust quality systems, ultimately ensuring the delivery of safe and effective therapies to patients.
Responsibilities:
Conduct supplier audits and assessments to evaluate and qualify new and existing suppliers.
Collaborate with cross-functional teams to establish criteria for supplier selection and approval.
Develop and maintain quality agreements with critical suppliers, outlining expectations and quality standards.
Ensure adherence to quality agreements by conducting regular reviews and updates as needed.
Foster strong relationships with suppliers through effective communication and collaboration.
Act as a liaison between internal teams and suppliers to resolve quality issues and drive improvements.
Requirements:
BS life sciences
5-10 years of experience in QA within biologics, with a focus on maintaining supplier quality program
Experience establishing quality agreements, performing supplier audits, and managing supplier change notifications
Experience communicating directly with the FDA, clients, and other external bodies during regulatory inspections and client audits
Experience conducting internal audits to assess compliance with quality systems and identify areas for improvement.
Support external audits by regulatory authorities and clients, ensuring a high level of readiness and responsiveness.
#M3
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.