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Quality Assurance Specialist II

Takeda Pharmaceutical

This is a Contract position in Surry Chase, GA posted May 13, 2022.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:You will support a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for testing, purification, and fill finish for its biologic medications.How you will contribute:Provide Quality oversight and manufacturing support by Operations Perform review of batch record documents on the shop floor Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices Provide manufacturing floor coverage and attend daily meetings Identify nonconformance’s and participate in investigation and Corrective and Preventative Action (CAPA) activities Use of Quality Systems to assess product impact or review data Author, review, or approve written Standard Operating Procedures (SOPs) and submit procedural changes to meet requirements Experience with Trackwise, EBM, and Delta V/PLC Negotiation and Problem Solving abilities 2+ years of experience required in the pharmaceutical or other similarly regulated industry is preferred.What you bring to Takeda:BS in Science / engineering or equivalent experience required in the pharmaceutical or other similarly regulated industry. Must have knowledge of and understand application of Good Manufacturing Practices (GMP)What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Professional training and development opportunities Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines May be required to work off-hours, and extended periods of timeMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants.#GMSGQ#ZR1#LI-MA1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsUSA – GA – Social Circle – Hwy 278Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time