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Quality Assurance Specialist II

Company: Takeda Pharmaceutical
Location: Loganville
Posted on: September 23, 2022

Job Description:

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 Description About the role: As the Quality Assurance Specialist II, you will support the fractionation facility that brings Takeda additional capacity for Fractionation, testing, purification and fill finish for its biologic medications. You will provide Quality Assurance support for Fractionation process and providing Quality oversight and manufacturing support. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members. You will work on multiple projects, demonstrate effectiveness in task completion, empowerment of others, exception management, training, problem solving and team leadership. This role is covering the weekend shift, working Friday, Saturday and Sunday from 6:00 PM to 6:30 AM and one other eight hour shift biweekly.How you will contribute:

  • Lead ongoing, daily departmental Quality Assurance support for Fractionation process and EBM efforts.
  • Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with production supervisors, engineering, and other internal groups.
  • Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques
  • Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities
  • Provide training and coaching to local employees and others on relevant area(s).
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements.
  • Participate in QA multi-site projects in the role of contributor, coordinator, or lead.
  • Other responsibilities, tasks or projects as assigned.What you bring to Takeda:
    • Typically requires Bachelors in Science / Business
    • In lieu of degree, 3+ years experience in Quality with a medical device/Pharma company or other similarly regulated industry.
    • Can encourage teamwork and drive decisions.
    • Must have computer experience (knowledge of Microsoft Word, Excel (can perform complex functions) and PowerPoint required
    • Knowledge of TrackWise, Delta V and Electronic Batch Record Management is ideal
    • Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
    • May be required to travel to local and international work locations.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:
        • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
        • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
        • Work multiple shifts including off hours, weekends, or be asked to work supplemental hours, as necessary.
        • Work around chemicals such as alcohol, acids, buffers and Aerosil that may require respiratory protection.More 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. EEO Statement Takeda 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. Locations USA - GA - Social Circle - Hwy 278 Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Roswell , Quality Assurance Specialist II, Other , Loganville, Georgia

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