Quality Assurance Specialist II

Company: Takeda Pharmaceutical
Location: Good Hope
Posted on: May 16, 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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:As the Quality Assurance Specialist II, you will support the operation of 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. You will release production lots for Fractionation, IG and Albumin. You will demonstrate effectiveness in task completion, empowerment of others, exception management, training, and problem solving. You will report to the Supervisor, Quality Assurance.How you will contribute:

• Provide Quality oversight of operation activities, review batch related document
• Use Electronic Batch Management (EBM) system
• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices.
• Work with functional peer, and provide coaching, training and development of your team.
• Perform QA Release Function:
• Complete product C of As
• Release production lots based on product specifications
• Update metrics biweekly
• Maintain task Tracker
• Follow up with supporting departments on deliverables
• Identify and escalate issues
• Perform product holds of lots
• Review documentation for accuracy and compliance to procedures and specifications, and release and reject
• Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements
• Promote continuous improvements through participation (i.e. team leader/facilitator or major contributor) in the Quality Improvement Program.
• Participate in QA multi-site projects in the role of contributor, coordinator or lead.
• Knowledge of TrackWise, LIMS and Electronic Batch Record Management preferredWhat you bring to Takeda:
  • Typically requires a BS in Science / Business or equivalent.
  • 3+ years of experience in Quality with a medical device/Pharma company or other similarly regulated industry.
  • Can encourage teamwork and drive decisions.
  • Have computer experience (knowledge of Microsoft Word, Excel (can perform complex functions) and PowerPoint
  • Have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.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 in a cold, wet environment.
      • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
      • Work around chemicals such as alcohol, acids, buffers and Celite 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.#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

Keywords: Takeda Pharmaceutical, Atlanta , Quality Assurance Specialist II, Other , Good Hope, Georgia