Quality Assurance Specialist II

Company: Takeda Pharmaceutical
Location: Peabody
Posted on: August 6, 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 Direct responsibilities include:Day shift 6am to 6:30pm (Mon thru Thursday)(every 3rd week will work weekends and may also include holidays)

• You will perform functions following cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
• Proficiency with Microsoft applications, Excel (can maintain complex spreadsheets), Project.
• Focus, as the need arises with new software applications.
  • Observe domestic and international GMP regulations, cGMP's, and company policies.
  • .Excellent communications both orally and in writing.Education and Experience RequirementsB.S associates degree in science or engineering with at least 3 years relevant experience or equivalent work experience, developing, and administrating GMP quality programs in cGMP biotech or pharmaceutical environmentsLiving our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
    • Perform functions following cGMP guidelines. Knowledge of regulatory requirements and guidelines for US and Europe.
    • Observe domestic and international GMP regulations, cGMP's, and company policies.
    • You will meet challenging timelines, in spite of obstacles.
    • You will work with others on the team tactically, balancing work as workload changes to independently accomplish department goals and motivating, in spite of obstacles
    • Understand the needs of main collaborators and customers.
    • Can define sound QA systems' approaches and principles.
    • Demonstrate unwavering ethics and respect for all customers. Practice, building authentic relations.
    • You will need to embrace change when faced with challenging circumstances, find creative ways to handle changes..
      • Seek the input of others before making a decision. Demonstrate personal, balance personal needs with Takeda's needs.
      • You will have authority to make those decisions that must be referred to a higher level.
        • Impowered to make strategic Quality Assurance decisions including trouble shooting.
        • Receive general instructions on new work; refer to policies for guidance .Work is reviewed for technical soundness and accuracy.
        • You will report to the Associate Director of Quality Assurance.
          • Contacts are with other Internal professionals in the group (quality),manufacturing, facilities and regulatory.Other Job Requirements
            • You will be asked to work late shifts and weekends on ad-hoc basis.
            • Bring Excellence
            • Self-KnowledgeWhat 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
              • Flexible Work Paths
              • Tuition reimbursementMore 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 to 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 provide Better Health and a Brighter Future to people around the world.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. 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 - MA - Alewife - BIO OPS Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Peabody , Quality Assurance Specialist II, Other , Peabody, Massachusetts