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 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 on
cross-functional project teams and ensure our quality culture is maintained. A
typical day will include:
- This individual will be responsible for
lot review/release activities for commercial drug substance, drug product and
finished goods manufactured by international CMOs.
- This individual will support project
activities, validation, investigations, product complaints, and other quality
systems as they relate to commercial manufacturing.
- This person will be critical in
providing quality oversight and coordination of QA activities at CMOs.
- This person will be responsible for
coordinating/performing assigned investigations including drafting excursion
reports for review.
- This person will be responsible to
participate in assigned project teams as QA representative.
- This person will be responsible to draft
and implement change controls.
Responsible for managing own workload from multiple project managers to
- Performs documentation review
thoroughly, with a high attention to detail, using working knowledge of quality
concepts and internal procedures and controls.
- Perform reviews of deviations and
investigations, equipment, process and method validations as well as of
executed batch records.
- Maintains sufficient expertise in one or
more QA disciplines to independently perform analysis and draw appropriate
conclusions. Communicates with manager
and other stakeholders (internal and external) to ensure communication of
- Responsible for leading departmental
projects for process improvement and other projects as assigned by their
- Responsible for actively participating
in group training and coaching efforts. Positively influences peers in
achieving operational and project initiatives and objectives. Is a recognized
technical and procedural resource for peers.
- Proactively monitors discipline of
expertise for issues. Initiates solutions and preventative actions.
- Maintain Master Batch Records and
provide support for regulatory filings and change controls.
- Provide support for regulatory
inspections and GMP audits.
- Responsible for engaging in regular
contact with external organizations.
Acts as liaison with new vendors and independently resolves issues with
- Responsible for independent technical
and non-technical troubleshooting.
Serves as a representative to cross functional troubleshooting
- Identifies and resolves basic technical
issues using problem-solving skills, in consultation with Manager.
- Independently revises
department-specific controlled documents.
- Responsible for independent decision
making and routine issue resolution. Keeps Supervisor informed of activities
- Participates in required training and
keeps training files current.
- Independently performs assigned tasks in
the design and implementation of departmental process changes and other
projects as assigned.
- 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 improvements.
- 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
- BS and 4+ years experience with 2 in QA
or related compliance experience or MS and 2+ years QA experience. Experience
may be substituted for degree.
- Solid understanding of applicable
regulations and guidance. Demonstrates expertise of department processes, tools
- Ability to handle multiple tasks
concurrently and in a timely fashion.
- Good interpersonal skills and ability to
work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written
communication skills and ability to communicate effectively with site
personnel, peers and management.
- Must have the following personal
attributes: integrity and trust, work ethic, sound judgment, intellectual
honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office
applications, especially Word, Excel and PowerPoint.
- 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 Contribution Plan
reimbursement Company match of charitable contributions
- 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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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