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
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