you looking for a patient-focused company that will inspire you and support
your career? If so, be empowered to take charge of your future at Takeda. Join
us as a Quality Assurance Specialist III, Oncology and Biologics in our Cambridge, MA office.
everyone matters and you will be a vital contributor to our inspiring, bold
mission. As a Quality Assurance
Specialist III working on the Quality
Assurance team, you will be empowered to represent Takeda in managing lead
and support project activities, investigations, and other quality
systems as they relate to commercial manufacturing, ensuring that quality culture is maintained. A typical day
- The Quality Assurance Specialist III
will lot review/release activities for commercial drug substance, drug product
and finished goods manufactured by Contract Manufacturing Organizations on
behalf of Takeda Boston Oncology & Biologics. This includes: review of
executed batch records, maintenance of Master Batch Records, and providing
support for change control, and support for regulatory inspections and GMP
- The QA Specialist III will maintain
sufficient expertise in one or more QA disciplines to independently perform
analysis and draw appropriate conclusions.
- Responsible for communications with
management and other stakeholders internal to ensure communication of outcomes.
- Responsible for participating in departmental
projects for process improvement and other projects as assigned by their
- Responsible for actively participating
in group training. Positively influences peers in achieving operational and
project initiatives and objectives and serves as a recognized technical and
procedural resource for peers.
- This person will be responsible for
coordinating/performing assigned investigations including drafting excursion
reports for review.
- Able to identify complex problems and
consistently propose solutions. Reviews goals and plan regularly and realign
priorities consistent with organizational shifts. Continually seeks creative process
- Actively integrates big picture
understanding into all interactions. Drives team cooperation and credibility
focusing on positive results. Encourages communication, cooperation and win/win
- Responsible for coordinating activities
to administer assigned tasks. May coordinate activities cross functionally.
- Influences others to focus on goal
attainment by actively generating solutions to wide range of challenges.
EDUCATION, BEHAVIORAL COMPETENCIES AND
degree and four (4) years experience in Quality Assurance or related
compliance experience or MS and two (2) years Quality Assurance experience (experience
may be substituted for degree).
least two (2) years floor experience in a pharmaceutical manufacturing facility
under a GMP environment.
understanding of applicable regulations and guidance with ability to demonstrate
expertise of department processes, tools and methods.
to handle multiple tasks concurrently and in a timely fashion.
interpersonal skills and ability to work effectively and efficiently in a team
environment to accomplish goals.
verbal and written communication skills and ability to communicate effectively
with site personnel, peers and management.
have the following personal attributes: integrity and trust, work ethic, sound
judgment, intellectual honesty, pragmatism, courage and conviction.
be experienced in Microsoft Office applications, especially Word, Excel and
- Willingness to travel to various
meetings or client sites, including overnight trips.
- Requires approximately 0-10% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement
- Tuition reimbursement Company match of charitable
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO
employer of minorities, women, disabled, protected veterans, and considers
qualified applicants with criminal histories in accordance with applicable
laws. For more information, visit
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